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Senior level Quality Engineer with experience in high volume electronics, highly regulated industries, FDA QSR, Medical Device Regulations, ISO13485, ISO14971, IEC62304/82304, and IEC62366. Excellent understanding of quality principles, systems, methods, and tools. Team lead with responsibility and accountability to the organization for decisions and actions, while also holding others accountable for the same for product quality and compliance for sustaining & NPI programs. I spent many years in the consumer electronics field in supplier quality, reliability, EMC/EMI/ESD and other related roles before switching gears to medical devices in 2009. Ultrasound, AEDs and Defibrillators, and cosmetic medical devices.Gained knowledge & experience working for Crane Aerospace in 2022/2023 about aerospace industry standards such as DO-178C/B, DO-254, DO-330, AS9100D, AS9115A, AS9145 and more. Aerospace is as highly regulated as the medical device industry.I seized the opportunity to work with Philips Emergency Care group in December 2018 and returned to Philips in 2023 as a Sr. Mfg QE. As a Principal Product QE, Supported NPI projects that will have significant impact on customer care integrated solutions. Challenging work within two QMS systems as the company transitioned into a PDLM system. Represented Philips as an industry expert on the AAMI standards committee for the defibrillator particular standard, 60601-2-4. I worked with cosmetic medical devices at Solta Medical. Completing work toward IEC 60601-1 Ed. 3.1 compliance and working to meet IEC 60601-1-2 4th Ed. EMC/EMI compliance. Supporting sustaining projects and NPI. As a Sr. QE at Physio-Control, represented the company for 3-years as an industry expert on the AAMI standards committee for the defibrillator particular standard, 60601-2-4. Clarifying aspects of testing & requirements in the standards. Impacting standards content and engaging in technical discussions with AAMI members from different companies and countries. Quality & Safety Compliance professional with proven skills in Technical Files; ISO 17025; ISO 13485; CE-Mark Self Certification; MDD/MDR and RoHS compliance; Risk Management; Witness testing (60601-1, Collateral & Particular standards); ISO 9001; AS9145; IEC 600/610 and other industry standards.Collaborating in reviews for SW and HW Product Requirement Documents, Hazard Analysis, FMEA, EMI/EMC, certification tests, protocols/reports, RoHS, Reach, WEEE and Environmental safety standards. FAA, FCC standards, Industry Canada, C-Tick, CE-mark, RTT&E and other Directives.
Percussionaire®
View- Website:
- percussionaire.com
- Employees:
- 30
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Quality Assurance ManagerPercussionaire®Ponderay, Id, Us
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Sr. Manufacturing Quality EngineerPhilips Apr 2023 - PresentAmsterdam, Noord-Holland, NlQuality Engineer supporting manufacturing in the Emergency Care - Home and Public (EC-HP) business. Responsible for leadership in the manufacturing area to ensure that products are made to business and customer expectations. Accountable to the organization for their decisions and actions in this mission, while also holding others accountable for the same. Responsible for successfully managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).• Driving quality in manufacturing• Participating in risk management activities• Assisting with the transfer of designs into manufacturing• Performing independent technical assessment on engineering or production deliverables• Leading quality related problem solving and root cause analysis during manufacturing including CAPA• Engaging with production teams to manage non-conforming product and to drive cost of non-quality reductions.• Using applicable data sources and statistics to report on product quality performance and taking action in accordance with data.• Ensuring that quality and compliance standards and regulations are met. -
Design Quality Assurance Engineer IvCrane Aerospace Jun 2022 - Apr 2023Crane Aerospace & Electronics supplies critical systems and components to the aerospace and defense markets. Crane Aerospace & Electronics can be found in some of the toughest environments: from engines to landing gear; from satellites to medical implants and from missiles to unmanned aerial systems (UAS).• Work cross-functionally with Engineering, Operations, Suppliers and Customers• Support Programs, perform test set-up verification and document peer reviews• Drive root cause analysis and recommends corrective actions• Produce reports regarding nonconformance of testing, products or processes, root cause analyses, or quality trends• Drive qualification of product and process changes to ensure only the highest levels of quality are accepted• Support audits with Defense, Aerospace and Customer Auditors• Provide support for failure analysis and reliability testing as required• Review/Approve quality document changes - Engineering Change Orders (ECOs), deviations
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Principal Product Quality Engineering LeadPhilips Jul 2021 - Jun 2022Amsterdam, Noord-Holland, Nl• Act as a single point of contact (person assigned to project team) responsible to ensure that system design meets quality and compliance standards for each milestone• Participate in Project Core Team for sustaining and NPI – project planning, discussions, decisions, risks identification and mitigations – quality, KPIs and compliance across teams, process and products considering: design, development, usability, reliability, performance, supportability, manufacturability, safety, security, privacy, serviceability, sustainability and cost• Involve in risks identification and mitigations – product and process quality, key characteristic identification and overall compliance oversight.• Participate in design reviews - independent oversight and review of project milestones and deliverables throughout product lifecycle. Ensuring that system design meets quality and compliance standards• Participate in product requirements, risk hazard analysis, verifications, and validation evidence reviews. Checks and audits to assure completeness of the system verification and validation traceability.• Perform independent technical assessments and acceptance of on engineering or production deliverables - Proactively monitor and identify any gaps in design, development, and supporting processes• Review and approve engineering change orders related to product design control, design history file, TechFile, STED and supporting evidence.• Participate in special quality programs for the product quality continuous improvement activities – Standards Review Board, Health Hazard Evaluation team (HHE, RCE, CA) monitoring, reporting and problem solving.• Experience in medical device and accessories product lifecycle, software development lifecycle, Design, Development, System Verification & Validation.
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Principal Design Quality EngineerPhilips Feb 2020 - Jul 2021Amsterdam, Noord-Holland, NlAdding mentorship and leadership of three (3) Design Quality Engineers and two more NPI projects.
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Senior Design Quality EngineerPhilips Dec 2018 - Feb 2020Amsterdam, Noord-Holland, NlTaking action as a change leader to align quality practices developing medical device business to the Philips QA standards. Taking on the challenge to integrate a fast growing business in a corporate structure, while enabling market launches and growth. Utilizing my influencing skills, in-depth knowledge of relevant Quality Assurance practices, working knowledge of the regulatory context and understanding of design controls in a SW and HW development environment. Acting as a main interface between the QA team and development team. Facilitate meeting project goals in a compliant manner and understanding how quality policies and development processes interact. I work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales. Utilize my high level of understanding of product risk management and also able to work at the engineering level with designers to develop product risks, helping with severity levels and occurrence rates. Ensuring requirements are captured appropriately (as well as most other DHF items, inputs, outputs, V&V, transfer). • Support integration of a recently acquired medical device business in the Philips organization. • Manage Q-improvement and integration plans. • Mentor and coach a growing development team on compliance requirements. • Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies. • Release of finished devices for clinical tests and delivery to customers. • Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement. • Compliance, effectiveness and efficiency of the QMS and operations. • Collaborate with Business and Q&R Management to establish strategic plans and objectives
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Senior Quality EngineerSolta Medical, Inc. Sep 2017 - Dec 2018Bothell, Wa, UsSolta Medical, a Valeant Company, is a global leader in the medical aesthetics market providing innovative solutions with proven efficacy and safety backed by over 10 years of clinical study and research. The company offers aesthetic energy devices for skin resurfacing and rejuvenation, acne reduction, body contouring and skin tightening, as well as tools and accessories to optimize the latest liposuction techniques. The Solta Medical portfolio includes the well-known brands Thermage®, Fraxel®, Clear + Brilliant®, Liposonix®, Isolaz®, VASERlipo™, VASERsmooth™, VentX®, PowerX®, and Origins™, which collectively make up a comprehensive platform to address a range of aesthetic skin and body issues. Support daily production activities and review change orders for adequacy • Maintain current knowledge of federal, state, and international regulations regarding GMP, ISO, MDD/MDR, and quality assurance • Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings • Work with manufacturing engineering to plan, execute, and document process validations • Create Safety Agency Test and Certification Plans. Interface with Testing Agencies and provide oversight of CE and CB-Scheme testing and certification. • Participated in creation and review of new risk assessments and requirements for IEC 62304 compliance. • Participate in Regulatory Assurance activities as required • Participate in audits including internal, FDA and Notified Body -
Senior Compliance (Agency) Standards EngineerPhysio-Control, Now Part Of Stryker Jun 2014 - Sep 2017Redmond, Wa, UsDefibrillators and Accessories: Create Agency Plans, Project Team member, Standards liaison (identification of applicable standards for the project), Review product device changes, Assemble/Maintain certification documentation (DoC, TRFs, TDFs), Interface with Agencies, Oversight of SMT and CB-Scheme Testing and compile Laboratory/Test house data. Define EC directives applicable to product. Define and manage CE certification route for device class per MDD and other applicable directives.Standards: EN/IEC 60601-1, 1-2 (EMC). 1-6 (Usability), 2-4 (defib), 2-25 (electrocardiographs), 2-27 (monitoring), 2-49 (monitoring), IEC 62304 (SW lifecycle), and more depending on project.EC Directives: MDD/MDR, WEEE, EMC, RE-D (RTTE), REACH, RoHS, and Battery DirectiveUN Transport tests, EN 1789 (Road EMS), ISO 14971 (Risk Mgmt). ISO 10993 Biocompatibility -
Safety Compliance (Agency) EngineerFujifilm Sonosite, Inc. Apr 2009 - Jun 2014Bothell, Wa, UsDocument/Submit TRFs and safety agency reports for approval and certification (CB, CE, CAN/US to name a few). Perform safety hardware testing, generate test plans, protocols and safety compliance reports specific to portable ultrasound systems and accessories. Update system and accessory labels with Agency information. Working within 60601-1 and collateral standards (2nd & 3rd Edition). -
Quality EngineerLeviton Sep 2008 - Dec 2008Melville, New York, UsAerotek contract position through end of 2008 -
Sr. Quality EngineerAvocent Nov 2003 - Jun 2008Huntsville, Al, UsFull-time then contract position. Supplier quality support with OEM customers and overseas suppliers. Performed data analysis and evaluated returned product for failure trend analysis. -
Project CoordinatorAdic (Now Quantum) 2003 - 2003Documented process flows, created product option BOM structures and provided engineering support services. Coordinated change control and improvement processes.
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Manager, Engineering ServicesAppian Graphics Sep 1998 - May 2001UsManaged configuration control and hardware test engineering, provided quality engineering support. -
Sr. Quality EngineerMicrosoft Apr 1993 - Feb 1998Redmond, Washington, UsWorked with hardware (mice, keyboards, gaming hardware), OEM customers, retail product, returns, counterfeit hardware, Agency compliance, First Article Lab. -
Sr. Quality EngineerAppian Technology Inc. Jan 1991 - Feb 1993(Previously called Renaissance GRX) Developed, implemented, evaluated and maintained technical quality assurance systems. Improved inspection methods and procedures. Contributed as product team member for new product design and existing product enhancements. Worked directly with OEM customers on quality metrics.
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Sr. Quality EngineerRenaissance Grx Apr 1989 - Jan 1991Worked all avenues of quality engineering from creating test & inspection systems, to working with large OEM customers on quality planning and product assessments.
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Sr. Supplier Quality EngineerCompaq Computer Corporation Jun 1985 - Feb 1989Houston, Texas, UsHeld positions of Quality Engineer, Reliability Engineer, and Supplier Quality Engineer -
Quality EngineerAdvanced Input Devices Aug 1983 - Apr 1985Held positions of Quality/Manufacturing Engineer and Design Engineer
Linda Foster Skills
Linda Foster Education Details
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Patmos Engineering Services, Inc.Airborne Software Certification Training For Do-178C -
Oriel Stat A MatrixCertificate Of Completion: Transition To Iso 13485:2016
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Oriel Stat A MatrixCertificate Of Completion: Eu Mdr Transition Training
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Ul University2Nd Edition
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Montana State University-BozemanElectrical And Electronic Engineering
Frequently Asked Questions about Linda Foster
What company does Linda Foster work for?
Linda Foster works for Percussionaire®
What is Linda Foster's role at the current company?
Linda Foster's current role is Quality Assurance Manager.
What is Linda Foster's email address?
Linda Foster's email address is li****@****eae.com
What is Linda Foster's direct phone number?
Linda Foster's direct phone number is +142586*****
What schools did Linda Foster attend?
Linda Foster attended Patmos Engineering Services, Inc., Oriel Stat A Matrix, Oriel Stat A Matrix, Ul University, Montana State University-Bozeman.
What are some of Linda Foster's interests?
Linda Foster has interest in Social Services, Economic Empowerment, Education, Environment, Science And Technology, Animal Welfare, Arts And Culture, Health.
What skills is Linda Foster known for?
Linda Foster has skills like Quality Assurance, Medical Devices, Testing, Engineering, Cross Functional Team Leadership, Quality Control, Product Development, Manufacturing, Quality Management, Engineering Management, Product Management, Six Sigma.
Who are Linda Foster's colleagues?
Linda Foster's colleagues are Lori Bykerk, Gail Gage, Adi Babaduyan, Kyle Newell, Sherry Turner, Ian Elliott, Shawn Burns.
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