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Company Overview
Trelleborg Medical Solutions is Your Partner for Life-Changing Technologies. Trelleborg Medical Solutions forms lasting partnerships with customers to design, develop, manufacture and bring to market innovative engineered solutions for demanding medical device, biotech and pharmaceutical applications.
Summary
As a Quality Engineering Supervisor at Trelleborg Medical Solutions, you will be responsible for leading a Quality Engineering team and managing day-to-day activities to support production activities at the site, as well as providing leadership, functional management, and oversight of other designated areas.
Responsibilities
- Must be knowledgeable and adhere to TMS Quality Management System and its requirements.
- Drives and supports QMS initiatives and continuous improvement activities.
- Ensures direct reports are successfully performing their duties as assigned. Provides coaching on an ongoing basis.
- Ensure necessary training is defined, assigned, and excuted for the direct reports.
- Assigns projects and responsibilities to the direct reports. Ensures skill-sets of staff are in alignment with expected duties.
- Consults Quality Manager/Director on quality-related topics
- Establishes and develops site-specific processes as required/requested
- Reviews and approves processes, Quality Plans, protocols/reports, as necessary.
- Ensures proper resource allocation to support needs to ensure delivery expectations of customers
- Provides recommendations for goals and objectives for the Quality Department
- Supports and coordinates management of nonconforming issues such as complaint, nonconforming materials and events, audit findings, and CAPAs.
- Drives best practices through the application of effective quality engineering principals and procedures across functions
- Ensures proper controls are being systematically applied to products
- Supports internal and external audits
- Provides recommendations based on data for improvements that are measurable.
- Other duties as assigned
Qualifications
Required:
- 4 year degree in Engineering or Science-related field
- 4 years of increasing experience providing technical support and leadership in regulated environment
- Class I, II, III Medical Device and component manufacturing experience
- Experience in coaching and utilizing performance management tools and disciplines
- Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution
Desired:
- Knowledge and experience with one or more: ISO/FDA: ISO 9000/9001; ISO 13485, and 21CFR Part 11/820 (and 4/210/211 as applicable)
- Quality certifications (ASQ CQE, CQA, CQM, etc.)
- Experience auditing (internal and external) for all elements of ISO 9001 and/or ISO 1348
- Experience with the successful completion of multiple projects for new product development or improvement initiatives
If you are driven by a passion for Customer Focus, Performance, Innovation and Responsibility and want to make a significant impact in a dynamic manufacturing environment, we invite you to apply for the Quality Engineering Supervisor position at Trelleborg Medical Solutions.
Job Type: Full-time
Pay: $80,040.00 - $100,050.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- Medical Device manufacturing: 4 years (Required)
Work Location: In person
Salary : $80,040 - $100,050