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:
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
About Trelleborg Healthcare & Medical
Trelleborg Healthcare & Medical helps pharmaceutical and medical device companies improve patient quality of life. We do this by forming lasting partnerships with customers who seek our expertise to accelerate innovation; to ensure reliable, high-quality product supply; and to help design, prototype and manufacture life changing components and devices.