Summary:
A leading medical device company based in Minneapolis, MN, is in search of a Senior Quality Engineer specialized in Production. This role focuses on cultivating a culture of Quality and Continuous Improvement throughout the organization by ensuring adherence to Quality System standards.
The company, known for its innovative approach to medical contract manufacturing and expertise in intricate materials transformation for essential components used in diagnostics, wearable technologies, and electronic devices, is specifically seeking candidates with the following qualifications:
Production Focused Team: Acting as the quality representative within the Production Focused Team (PFT), guaranteeing adherence to customer, company, and regulatory standards in manufacturing and process enhancement. Providing on-the-floor quality support to address production issues and ensure proper utilization of process controls. Investigating and resolving customer complaints, nonconformances, and supplier quality issues.
Responsibilities encompass, but are not confined to:
Adhering to Quality Management System requisites and company protocols, ensuring regulatory compliance, and fostering team adherence. Fulfilling commitments punctually with precision and attention to detail. Staying current with medical device regulations (FDA QSR, ISO 13485, ISO 14971).
Collaborating with Development, Production, Quality, Sales, and Customers to create and execute:
- Risk assessments (PFMEAs)
- Quality and Control Plans
- Production and inspection procedures
- Test method development and validation
- Equipment IQ/OQ protocols
- Process qualification (OQ/PQ) protocols
- Statistical process controls
- Facilitating communication to identify and document nonconformities and product issues promptly.
- Using technical expertise and Root Cause Analysis to resolve product/process issues, implementing corrections and long-term solutions.
- Proficient in risk-based sample size determination and statistical data analysis, presenting findings accurately.
- Supporting continuous improvement and Lean initiatives, leading or sponsoring efforts.
- Leading risk assessments for new/modified processes and updating documentation.
- Providing expertise in Quality processes (supplier management, Material Review Board, Change Control, Calibration, Preventive Maintenance, Equipment controls).
- Serving as an SME during audits and participating in internal/supplier audits.
- Performing other duties or special projects as assigned by management.
Qualifications:
- A bachelor's degree in a scientific, engineering, or technical field.
- A genuine interest and commitment to process improvement.
- 7+ years of experience, including at least 3 years at the senior level, in the medical device or related manufacturing 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.
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
