Summary of Role
Imagine leveraging your quality expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.
Trelleborg Healthcare and Medical is seeking a Supplier Quality Engineer to join their team. You will be responsible for managing supplier quality and leading the CAPA program for supplier non-conformances. Working with internal and external customers, supports supplier quality and continuous improvement using appropriate tools and project leadership.
As a valued Trelleborg team member, you will enjoy:
- Greater opportunity for impact
- Competitive compensation
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
- Paid time off
- 4-year degree in Quality Engineering or related field
- ASQ Certified Supplier Quality Engineer/ Auditor
- 2+ years working within GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820 (210/211 and ICH Q7 as applicable)
- Maintains Approved Supplier List (ASL)
- Assesses potential new suppliers for technical, quality, and manufacturing capabilities
- Supports Engineering and Inspection groups in analysis of incoming material defects
- Participates in Material Review Board (MRB) activities to disposition nonconforming material per process
- Coordinates with suppliers and identifies areas for supplier quality improvements
- Supports ongoing business and new product development introductions through managing the quality supply chain
- Supports Purchasing and Engineering group in supplier selection, either by identifying existing approved suppliers or new suppliers
- Develops and maintains the annual supplier audit plan. Schedules, prepares and conducts supplier site audits to determine the state of a potential supplier’s quality system in relation to ISO 13485, ISO 9001, and 21CFR Part 820 (and 210/211 and ICH Q7 as applicable). Ensures supplier audit findings are tracked to timely and adequate closure.
- Supports all necessary site audits (internal and external) as related to Supplier Management
- Conducts material supplier assessments, notifies supplier of nonconformances, issues SCARs, and reviews corrective actions and follow up activities
- Responsible for escalation, leading risk assessments, risk mitigations and communicates supplier risks based on performance
- Works closely with the supplier to develop control plans and support change control activities
- Leads cost reduction projects related to quality improvements to supplied materials and products
- Reviews supplier performance data and participates in the Supplier Score Card process
- Tracks, analyzes, and reports on supplier performance to management and other team members as necessary.
- Manages all nonconformances related to Supplier Quality processes