Provide quality leadership to new product development projects, manufacturing process control and vendor qualification and/or management. Assist manufacturing group with the quality assessment of product issues for production and sustaining engineering support.
DUTIES AND RESPONSIBILITIES (essential functions of position):
- Oversee qualification activities and manufacturing support for medical devices, including IQs/OQs/PQs.
- Develop and oversee execution of measurement equipment qualifications and test validations
- Participate in project cross-functional teams for new product development to complete Design Control Deliverables, including design reviews, risk management, D/PFMEAs and verifications and validations.
- Interface with Product and Manufacturing Engineering to identify and resolve product quality issues and lead reviews of such issues through the Internal Audit Program, CAPAs, NCRs and complaint reviews.
- Develop and maintain company’s QMS through quality SOPs for compliance with standards and regulatory requirement.
- Develop and maintain DHFs to establish Quality Plans, Measurement and Test Equipment Matrix ,CTQ parameters, sampling plans and acceptance criteria.
- Complete and/or review DCRs in a timely and objective manner.
- Monitor and report quality metrics in order to identify and implement CI initiatives.
- Participate in internal, suppliers as well as regulatory body audits.
- Interface with Engineering and Purchasing in all activities involving supplier identification, qualification and management.
ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s degree in engineering or related discipline.
- 5+ years in the medical device or related industry.
- Must possess excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, test method development and validation, test execution, failure analysis and risk management.
- Expertise in FDA 21 CFR 820 regulations, ISO 13485, ISO 14971.
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Strong root cause analysis and statistical techniques skills.
- Strong sense of urgency, initiative and teamwork.
- Ability to travel approximately 20%, including internationally.
- Professional with Microsoft Applications such as: Word, Excel, Outlook, Power Point and Visio.
NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):
- Experience in the implantable medical device field with experience in Design Assurance, Quality Assurance, Design Controls and Risk Management.
- An American Society of Quality Engineers (ASQ) certification is preferred (CQA, CQE, CSSGB)
- Familiar with the following standards/regulations: Medical Device Regulation (MDR), Council Directive, Regulation (EU) 2017/745, Guidance on CE Marking.
- Advanced knowledge of CAD software packages (AutoCAD, SolidWorks, etc.) and application of GD&T.
- Experience with statistical software packages or add-ons such as Minitab, SigmaXL, etc.
**To apply for this opportunity, please send a resume and cover letter to email@example.com referencing: QA Engineer