Are you looking for a new and exciting opportunity where you can use your expert skills yet constantly learn new things? Do you desire a fast-paced place where you can get ahead on merit rather than seniority? Are you an expert at becoming an expert, and are always looking for new ways to grow? If you have a desire to work in a collaborative and creative environment filled with talented and positive people, then check out this opportunity.
We are looking for a Quality Engineer to join our team! This person will be responsible for providing documented statistical and technical direction, as well as support for projects and products to ensure we meet customer requirements.
- Manage, lead and facilitate RCA, CAPA, PAR and NC utilizing in Process Flow mapping, FMEA, and other product development quality activities.
- Develop and analyze in process data to provide trend analysis to statistically troubleshoot part quality issues and provide recommendations to internal and external customers.
- Establish plans, drive, and document results related to quality for activities such as APQP, PPAP, IQ, OQ, PQ, FMEA, DOE, GRR, NPL, PVP, PVR, MVP work instructions, control plans etc.
- Manage quality related aspects of assigned product lines and manufacturing processes to ensure the highest product quality and assure compliance to specifications and standards (i.e. ISO, AS, GMP, etc.)
- Mentor and teach quality engineering tools such as SPC, Gage R&R and others. Teach Six Sigma methodologies and advanced statistical applications to Engineers and staff.
- Ensure quality standards are the expectation in the organization; execute quality plans, sampling plans, control plans, and measurement methods, as well as performing measurement method analysis.
- High School Diploma/GED required
- BS in Engineering strongly prefer, or equivalent work experience required
- 3 years experience in med device or component manufacturing
- Demonstrated knowledge of ISO 13485:2003, ISO 9001:2008, CFR-820 Regulations
- Quality Systems, such as ISO, AS, GMP
- Quality/Production Processes, such as PPAP, IQ, OQ, PQ, FMEA, CONTROL PLANS, DOE, GRR
- Quality Systems Regulations
- Key Competencies:
- Excellent written and verbal communication skills
- Analytical thinking to interpret data and report quality impact
- Critical thinking and problem solving to evaluate options and implement solutions
- Travel: Up to 10% of time
- Physical Requirements:
- Routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets
- Periodic to continuous standing, walking, kneeling, bending, reaching, talking, seeing, hearing
- Exposure to heat, noise, dust, dirt, oil and water in a manufacturing environment
MMD offers top wages for experienced candidates. The compensation package will consist of an attractive and competitive market based salary, which will be determined, in part, by the successful candidate’s level of manufacturing experience. Pre-Employment background check and drug screen required. EOE/M/F/D/V/E-Verify.