Grand Rapids, MI
Job Title: Quality Engineer
Rapidly expanding medical device manufacturing company is in search of a detail oriented, customer centric Quality Engineer. This position is responsible for supporting high standards of precision and quality products for both internal and external customers.
DUTIES AND RESPONSIBILITIES
- Establish and participate in supplier qualification/development activities.
- Lead/Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
- Lead/Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
- Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
- May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
- Perform analysis of reports and production data to identify trends and recommend updates to changes to the Quality System Regulations, Standards, and/or guideline procedures when necessary.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
- Maintains statistical process controls by applying demerit/unit, zone charting, and x2 charts for distributions and individual-medial/range for multi-stream processes.
- Contributes to team effort by accomplishing related results as needed.
- 100% paid family health benefits
- Quarterly bonus paid
- Uniforms, work boots and safety glasses allowance
- Long term/short term disability insurance
SPECIFICATIONS (SKILLS AND ABILITIES)
- Strong interpersonal and presentation skills needed to interact with external customers as well as with all levels within the company.
- Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.
- Thorough Knowledge and experience surrounding quality control inspection.
- Thorough knowledge of ISO 9001 and ISO 13485 standards and FDA 21 CFR part 820
- Minimum Bachelor’s Degree in an Engineering or Science discipline
- Green Belt or ASQ certification a plus.
- Proven problem solving experience
Research & Recruitment Specialist
Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.
With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.
Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.
Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.