Excellent growth opportunity with a well-established medical device firm with an aggressive growth strategy and the revenues and resources to enable it. The company has a highly successful operation developing and manufacturing precision, high volume devices as the OEM provider of choice for major international players and top-flight hospital systems.
You’ll be a vital part of a well-organized department with seasoned leadership that is committed to producing high quality, life-saving products. Varied responsibilities include overseeing the internal audit program, maintaining the supplier quality program, performing failure investigations, managing CAPAs, customer complaints and compliance requests.
- Support compliance with cGMP, QSR, ISO 13485 and 14971, MDD/MDR, and other standards.
- Plan, implement, investigate SCARs and CAPAs; perform root cause investigations, verification plans, corrections, and follow up with suppliers.
- Investigate, evaluate, report adverse event incidents or device malfunctions.
- Identify statistically based sampling plans for inspections and testing.
- Provide support of NCR and complaints, perform investigations, material dispositions.
- Qualify and manage suppliers, perform supplier audits, performance reviews, and scorecards.
- Facilitate the execution of Risk Management activities.
- Conduct Gage R&R and validations.
- Participate in internal and external audits and FDA inspections.
- Support Post-Market Surveillance activities.
- Collect and report quality metrics and data.
- Communicate with customers and suppliers regarding compliance information and issues.
- Identify and implement opportunities for continuous improvement.
- BS or MS in Engineering, Science, Statistics, or Math; CQE and/or CQA certifications are a plus.
- 4-10 years medical device Quality Engineering experience in a manufacturing environment.
- Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Six Sigma, Lean manufacturing).
- Knowledge of statistical sampling and analysis.
- Strong knowledge and use of applicable FDA QSR, ISO, and EU MDR concepts and guidelines.
- Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T).
- Strong analytical, problem solving, organizational, verbal and written report writing skills.
- Proficient in MS Office Suite, Visio, Project and MiniTab.
- Ability to work in a fast-paced environment and meet tight deadlines.
- Sterile background a plus.
- Available for occasional domestic travel.