A distinguished contract manufacturing company headquartered in Minneapolis, MN seeks a Senior Quality Engineer focused on Production tasked with fostering a Culture of Quality and Continuous Improvement across all departments by ensuring compliance with Quality System requirements.
Daily responsibilities include:
- Adhering to all Quality Management System requirements and company protocols to meet regulatory standards, while encouraging associates to do the same.
- Fulfilling commitments promptly with precision and meticulous attention to detail.
- Staying updated on relevant medical device regulations (FDA QSR, ISO 13485, ISO14971) and associated standards or guidance documents.
- Serving as a subject matter expert for external audits as necessary and participating in internal or supplier auditing teams.
- Providing technical expertise and support for various Quality processes, including supplier management, Material Review Board, Change Control, Calibration, Preventive Maintenance, Equipment controls, Environmental controls, and other relevant processes.
- Collaborating with Development, Production, Quality, Sales, and Customers to develop, document, and execute/implement risk assessments (PFMEAs), Quality Plans, Control Plans, production and inspection procedures, test method development and validation, equipment installation qualification (equipment IQ/OQ), process characterization, statistical process controls, and related protocols and reports.
The ideal candidate will possess:
- A bachelor's degree in a scientific, engineering, or technical field.
- A genuine interest and commitment to process improvement.
- 7-8 years of experience, including at least 3 years at the senior level, in the medical device or related industries, with direct experience relevant to the job responsibilities.
- Proficiency in statistical techniques, data management, investigation techniques, and technical writing.
- Six-Sigma Green Belt (or higher) certification is highly desirable.
- Well-developed written and verbal communication skills, with the ability to present information effectively to various stakeholders.
- Capacity to manage multiple projects simultaneously, accommodating and delivering on deadlines.
- Ability to generate graphs and tabulate data using appropriate software for data presentation.
Benefits Offered:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
