- Co-ordinate project activities with teams, communicate progress, collaborate on key deliverable, and meet critical phase timelines.
- Providing continuous and rigorous assessment of Material Controls 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 controls 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.
- 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
- Bachelor's degree in life science, Quality, or Engineering field.
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Quality Engineer II - Arden Hills, United States - US Tech Solutions
Description
Duration:12+ Months Contract (Possible Hire for the Right Individual)
Job Description:
The Quality Systems Engineer for Supplier Controls will serve as a representative and will support assigned departmental goals and priorities.
Responsibilities:
Required Experience :
Skills:
Education:
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
US Tech Solutions is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name:
kanika
Email:
Internal Id:
#J-18808-Ljbffr
