A medical device company is looking for a Quality Engineer to join their team! In this position, you would play a key role in the manufacture and distribution of this company’s innovative products, managing activities related to internal and external quality and regulatory compliance. The ideal candidate is an analytical thinker with strong attention to detail and previous experience in the medical device industry. This is an excellent full-time, direct-hire opportunity!
Responsibilities of the Quality Engineer
- Develop, document, and implement QA procedures
- Interpret and assess conformity to appropriate regulatory standards
- Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
- Create suitable data analysis tables and report findings based on statistical evidence and trending
- Provide analytical investigations and develop root cause for non-conformances and deviations
- Design and specify gauging and test equipment for quality assurance functions
- Write protocols, analyze data, and generate summary reports for verifications and validations
- Lead and participate in design control projects for new and changing medical devices
- Interface with vendors and customers as required
- Complete and review documentation for accuracy
- Collaborate with various departments to establish quality standards for new and existing products
- Participate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.
- Conduct supplier evaluations, qualifications, and quality audits
- Perform other duties as assigned
Qualifications of the Quality Engineer
- BS or MS in Engineering, or scientific disciple with 5-7 years of experience in the manufacture of medical devices/disposables (Class II) for the medical device market
- 3 years Medical Device industry experience
- Certified Quality Engineer or Quality Auditor (ASQ) preferred
- Experience with design control, process validation, failure investigations, root cause analysis, and the application of statistics to the practice of quality assurance
- Experience participating in FMEAs or other risk assessment activities
- Experience with supporting FDA and certified body audits
- Clean Room experience
- Team player with strong communication, interpersonal, and presentation skills
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings, and procedure manuals
- Must have a strong computer, math, writing, and problem-solving skills
- Expert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices
- Knowledge of standards applicable to Medical Device Safety Risk Management (ISO 14971 and device-related compliance standards)
- Knowledge of lean manufacturing principles
If you have the required qualifications and want to be an integral part of our client’s continued success, apply now for this Quality Engineer position!
About Leddy Group
We are Leddy Group . . . a privately owned, regional staffing company serving NH, ME, VT & northern MA since 1994. We are one great brand with multiple specialties: accounting & finance, administrative & office support, engineering, human resources, industrial, skilled manufacturing, legal, and nonprofit.
At Leddy Group, we combine a consistency of values and traits with a singular standard for quality and best practices. We hold each other accountable to those standards, measure success by the quality of our outcomes, and establish goals based on continuous improvement metrics. We utilize a methodology and process to assess skills and experience; however, identifying the right “fit” is equally important for both candidates and clients alike. Our goal is to exceed your expectations. Our success is tied directly to your satisfaction.