About the roleThe desired candidate will have prior experience as a Senior Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities include but are not limited to maintaining the supplier quality program (agreements, performance etc.), Supporting Customer Complaints; performing failure investigations; supporting Non-Conforming Material; managing corrective and preventive actions; supporting the internal audit program, execution of Gage R&R and validations and driving a continuous improvement program.
Please note this position is onsite in Wilmington Mass. We can only consider candidates who currently reside within reasonable commuting distance of our location.What you'll do- Investigation, evaluation and reporting of adverse event incidents or device malfunctions as required by FDA and international regulatory authorities
- Provide support of nonconforming material (NCR) and customer complaints, perform investigations, material dispositions, and communicate with customers and/or suppliers.
- Facilitate supplier corrective action (SCAR) subsystem, communicate with suppliers, and follow up on investigations and corrective action planning and implementation by suppliers
- Support corrective and preventive action (CAPA) subsystem, perform investigations, follow up on corrections, root cause investigations, corrective action plan, implementation, and effectiveness verification plan
- Perform the qualification of new and existing suppliers, perform supplier audits, monitor supplier performance provide scorecards, and other related supplier management activities.
- Facilitate the execution of Risk Management activities
- Conduct Gage R&R and validations as needed
- Identify statistically based sampling plans for inspections and testing
- Support activities to ensure compliance with cGMP, QMSR, ISO 13485, MDD/ MDR, ISO 14971 and other applicable regulations and/or standards
- Participate in internal and external (ISO, MDD/MDR, customer, supplier) audits and FDA inspections
- Support Post-Market Surveillance (PMS) activities as required
- Collect and report Quality metrics and data as required
- Identify and implement opportunities for continuous improvement
- Perform other Quality System related duties as required communicate with customers and or suppliers as needed providing compliance information i.e., RoHS, conflict materials, prop 65 etc. as needed.
- Communication of change notices as applicable
- Support development of control plans, validation plans and inspection procedures for new product development projects
QualificationsMinimum Requirements:- Bachelor's degree preferably in Engineering, Science or Math or equivalent/relevant experience including 5+ years' Quality Engineering in a manufacturing or industrial environment, preferably in an FDA/ISO regulated environment
- Knowledge of statistical sampling and analysis
- Strong Knowledge of ISO 13485, FDA QSR, ISO 14971 and EU MDR concepts and guidelines as well as other national and international regulations and standards
- Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
- Technical writing experience
- Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Six Sigma, Lean manufacturing, etc.).
Preferred Skillset:- Sterile background a plus
- Excellent organizational, verbal, written communication and problem-solving skills
- Reliability and attention to accuracy, detail, and timeliness; reporting and analyzing information skills
- Able to work in a fast-paced environment and meet strict deadlines
- Self-motivated and can work with minimal supervision
- Proficient in MS Office suite, Visio, Project and MiniTab
The pay range for this role is:
115,000 - 130,000 USD per year (Wilmington MA)
