Quality Engineer
Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead. Our people are Shaping Industry from the Inside. Why don´t you join us?
Take advantage of this rare opportunity to partner with one of the leading contract manufacturers in the world! Leverage your Quality Engineering experience in a role where you will be part of process of life-saving medical devices and enjoy the support and stability of an organization that has been in business for over 100 years.
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
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