Linda Foster Email & Phone Number

Ponderay, ID, US

Amsterdam, Noord-Holland, NL

• Quality 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.
• 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

• Crane 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.
• 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

Amsterdam, 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.
• 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

Amsterdam, Noord-Holland, NL

Adding mentorship and leadership of three (3) Design Quality Engineers and two more NPI projects.

Amsterdam, Noord-Holland, NL

• Taking 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.
• 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.

Bothell, WA, US

• Solta 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.
• 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.

Redmond, WA, US

Defibrillators 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.

Bothell, WA, US

Document/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.

Melville, New York, US

Aerotek contract position through end of 2008

Huntsville, AL, US

Full-time then contract position. Supplier quality support with OEM customers and overseas suppliers. Performed data analysis and evaluated returned product for failure trend analysis.

Documented process flows, created product option BOM structures and provided engineering support services. Coordinated change control and improvement processes.

US

Managed configuration control and hardware test engineering, provided quality engineering support.

Redmond, Washington, US

Worked with hardware (mice, keyboards, gaming hardware), OEM customers, retail product, returns, counterfeit hardware, Agency compliance, First Article Lab.

(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.

Worked all avenues of quality engineering from creating test & inspection systems, to working with large OEM customers on quality planning and product assessments.

Houston, Texas, US

Held positions of Quality Engineer, Reliability Engineer, and Supplier Quality Engineer

Held positions of Quality/Manufacturing Engineer and Design Engineer

Airborne Software Certification Training For Do-178C

Certificate Of Completion: Transition To Iso 13485:2016

Certificate Of Completion: Eu Mdr Transition Training

Certificate Of Completion, Iec 60601-1, 2Nd Edition

Bachelor Of Science - Bs, Electrical And Electronic Engineering