Quality Engineer II
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Arden Hill, MN
The opportunity will be one year with a strong chance for a long-term extension.Position Summary: The Quality Systems Engineer for Supplier Controls will serve as a representative and will support assigned departmental goals and priorities.
Primary Responsibilities/Accountabilities: - Co-ordinate project activities with teams, communicate progress, collaborate on key deliverables, and meet critical phase timelines.
- Providing continuous and rigorous assessment of Material control processes to ensure compliance with FDA regulations, ISO 13485, and Medical Device Requirements and applicable global regulations.
- Ownership of highly visible, global, systemic CAPAs.
- Determining and tracking actionable material control metrics to improve supply chain effectiveness, product quality and patient outcomes.
- Support information gathering and preparation activities for applicable Global Quality System meetings and forums (e.g
audits, signals reviews) - Facilitate change management with cross functional groups (Supplier Quality, Purchasing, Sourcing, IT and Analytic Teams).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
- Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications: - Bachelor's degree in life science, Quality or Engineering field.
- Proven experience (2-4 years) in manufacturing, quality, IT or regulatory/compliance environment.
- Excellent verbal / written communication, interpersonal, project management, organizational and analytics skills.
- Experience working in an FDA and ISO 13485 environment and an understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
- Must be proactive and be a contributing member of a highly visible team.
- Occasional travel may be required to support and facilitate workshops
If this job is a match for your background, we would be honored to receive your application.
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement
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