Validation Engineer jobs in Saint Cloud, MN

Trelleborg Healthcare and Medical is seeking a Quality Engineer to join their team. The Quality Engineer is responsible for proactively identifying, investigating and resolving potential and existing nonconformances. A strong technical background is required. Experience in a regulated industry (medical device, pharmaceutical, automotive/transportation, etc.) is beneficial. This is a highly customer interfacing role. Advanced verbal and written communication skills are required for navigating potentially sensitive situations in a customer-focused organization.

As a valued team member with Trelleborg, you will enjoy:

• Competitive compensation:
• Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
• Greater opportunity for impact: You will impact the production of life-saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement.
• Bonus

Education and Experience

Required:

• Bachelor Degree in Engineering or other Technical discipline

(other relevant academic or professional qualifications and experience may be considered in lieu of an Engineering/Technical degree)

Desired:

• Lean/Six Sigma certification (Green Belt or higher)
• ASQ Certified Quality Engineer, Reliability Engineer, or Lead Auditor
• Professional training based on ISO 13485, ISO 9001, ISO 14971 and ISO 16949
• Professional training in defect prevention and detection

Job Responsibilities:

The position includes responsibility for leading and supporting Quality Systems and disciplines, including:

• Control of nonconforming material
• CAPA
• Complaint Handling/Customer Feedback
• Equipment Control/Metrology/Calibration
• APQP and Validation
• Document Control
• Supplier Quality
• Internal & External Audits
• Continuous Improvement

Competencies

·        Statistical tools and techniques (Minitab, SPC, normality, capability, probability, DOE, etc.)

·        Continuous Improvement tools and techniques (Kaizen, 5s, etc.)

·        Root Cause analysis (Ishikawa, FMEA, Is/Is-Not Analysis, 5Why, etc.)

·        Process validation (IQ/OQ/PQ, PPAP, APQP)

·        Test method validation (GR&R, ATMV, etc.)

·        Geometric Dimensioning & Tolerancing

·        VMM/CMM programming

·        Experience with injection molding and/or medical assembly

AAP/EEO Statement:

Equal Opportunity Employer, including disabled and veterans.