Caroline Bartlett, Asq Cqe Email & Phone Number

Marlborough, Ma, Us

- Lead and develop a team of five quality engineers who support medical device new product development, instrument manufacturing, and high volume automated manufacturing at three distinct sites in one harmonized quality system- Represent Quality as part of a cross-functional strategic site leadership team- Implement and drive the Operational Excellence program using the Shingo Model to improve company culture and behaviors, create and maintain systems and tools, and achieve ideal results- Sponsor initiatives for continuous improvement projects in quality and engineering to meet new and changing regulations and state-of-the-art practices, including Test Method Validation, Process Validation, Design Controls, Risk Management, Production and Process Control, Non-Product Software Validation, and Lean Manufacturing- Defend the Quality Management System and relevant outputs during internal and external audits for ISO 13485:2016, MDSAP, and IVDR/MDR

Marlborough, Ma, Us

- Led Risk Management Process remediation efforts and Risk Management File remediation efforts for the Diagnostic (Cytology) Division in accordance with ISO 14971:2019 to support IVDR- Provided quality support for new product development and design change activities of medical device products following design control requirements and internal procedures- Provided engineering services and support for product manufacturing and quality control- Supported materials non-conformance investigation, disposition, and release activity- Identified, investigated, and implemented corrective and preventive actions- Worked with manufacturing engineering to ensure necessary process controls are in place- Wrote, reviewed, and approved reports for test method validation, design verification, design validation, and process validation (IQ, OQ, PQ)- Participated in supplier quality management assessment- Used statistical tools to analyze data, make acceptance decisions, and improve process capability

- Course Instructor for the ASQ Certified Quality Engineer Refresher course

Providence, Ri, Us

- Supported new product development by providing leadership and input to contract development teams in the design of highly complex medical devices- Reviewed, assessed, and approved product design milestones and deliverables throughout product development cycle to ensure compliance to customer and regulatory requirements - Created, managed, and executed test objectives, test plans, and schedules for engineering and design verification utilizing valid statistical techniques- Develop medical device manufacturing build plans and reports in accordance with good manufacturing practices (Device Master Record and Device History Record)- Responsible for accurate generation and evaluation of Design History File documentation and overall Quality System and ISO 13485 compliance- Facilitated the generation of the Risk Management File in accordance with ISO 14971 (Risk Management Plan, Hazards Analysis, FMEA, FTA, Risk Benefit Analysis, Risk Management Report)- Coordinated and supported execution of supplier qualification activities, including supplier auditing and communication of quality objectives- Guided and mentored other team members, including junior design assurance team members- Managed a small team of design assurance engineering contractors to achieve overall program goals- Performed supplier qualification activities, including supplier audits

Providence, Ri, Us

- Planned, conducted, and executed design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria- Worked closely with product development engineering and the client team to establish the system design specifications and product requirements- Collaborated with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles- Contractor: Nov 2016 - June 2017

Boston, Ma, Us

- Supported new product development activities, including generating design requirement specifications for the customer, system, and components- Ensured design outputs are traced to design inputs and documented with objective evidence- Reviewed and provided feedback on verification and validation test protocols and reports, including studies involving human tissue- Analyzed risk and complied risk management documentation, include Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk/Benefit Analysis- Ensured design verification and validation activities are conducted using valid and appropriate statistical tools- Participated in a core team for product development from concept throughout the product's lifecycle- Assisted in preparation of submissions to regulatory agencies, including 510(k)

Boston, Ma, Us

- Responsible for managing medical device complaint records, including accurate documentation, review of defective product investigations, and response directly to customers- Conducted higher level data analysis and utilized reporting tools with ability to verbally present data and results in a comprehensive, detailed, and organized fashion to senior management and external customers- Trained colleagues on complaint management processes and basic Minitab to identify statistical trends- Responsible for troubleshooting customer complaints with a cross-functional group, including field service, marketing, customer service, engineering, and manufacturing

Marlborough, Ma, Us

- Responsible for managing medical device complaint records in accordance with company policy and in compliance with government regulations. - Assessed and submitted Medical Device Reports (MDR) and Vigilance Reports to the FDA and the National Competent Authorities outside the United States