Summary:
A leading contract manufacturing firm based in Minneapolis, MN, is in search of a Senior Quality Engineer specialized in Development or 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:
As Senior Quality Engineer, you will be supporting either or both of the following teams based on assignment:
Development Focused Team: Serving as the quality representative within the Customer Focused Team (CFT), ensuring alignment with customer, company, and regulatory requirements. Collaborating with customers, process development engineers, and project managers to translate requirements into actionable process development strategies. Offering on-the-floor quality engineering support during developmental manufacturing phases.
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, nonconformities, and supplier quality issues.
Responsibilities encompass, but are not confined to:
- Adhering to all Quality Management System requisites and company protocols, ensuring compliance with regulatory standards, and fostering adherence among team members.
- Fulfilling commitments punctually, demonstrating precision, and maintaining meticulous attention to detail.
- Staying abreast of relevant medical device regulations (such as FDA QSR, ISO 13485, ISO14971) and associated standards or guidance documents.
- Collaborating with various departments (Development, Production, Quality, Sales, and Customers) to formulate, document, and execute:
- Risk assessments (PFMEAs)
- Quality Plans and Control Plans
- Production and inspection procedures, including incoming inspection requirements
- Test method development and validation, gage R&R
- Equipment installation qualification (equipment IQ/OQ) protocols and reports
- Process characterization, risk-based process operational and performance qualification (OQ/PQ) protocols and reports
- Establishment of statistical process controls
- Facilitating communication with customers and internal stakeholders to ensure timely identification and documentation of potential nonconformities and product issues according to company procedures.
- Leveraging technical expertise and employing industry-standard Root Cause Analysis methods to address product and process issues, implementing necessary corrections and long-term solutions.
- Offering proficiency in risk-based sample size determination and statistical data analysis, presenting findings accurately and tailored to the audience.
- Supporting continuous improvement (CI) and Lean initiatives, potentially leading or sponsoring such endeavors.
- Spearheading risk assessment activities for new or modified process development projects and reviewing and updating risk assessment documentation.
- Providing technical expertise across various Quality processes, including supplier management, Material Review Board, Change Control, Calibration, Preventive Maintenance, and Equipment controls.
- Serving as a subject matter expert during external audits and potentially participating in internal or supplier auditing teams.
- Undertaking any other relevant duties or special projects as delegated 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
