Overview
On Site
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Contract - 6+ mo(s)
Skills
DESIGN QUALITY ENGINEER
QUALITY ENGINEER
DESIGN ASSURANCE
QUALITY ENGINEERING
DESIGN CONTROL
RISK MANAGEMENT
REGULATORY COMPLIANCE
ISO COMPLIANCE
FDA COMPLIANCE
Job Details
Design Quality Engineer
Primary Responsibilities/Accountabilities:
Qualifications:
If this job is a match for your background, we would be honoured to receive your application!
Job Summary: Talent Software Services is in search of a Design Quality Engineer
for a contract position in Maple Grove, MN. The opportunity will be six months with a strong chance for a long-term extension.Position Summary:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, customer and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development. Functional Engineering Roles include: Design AssurancePrimary Responsibilities/Accountabilities:
- Responsible for design control and risk management of next-generation medical devices.
- Uses clinical knowledge to influence how devices they are working on are tested and designed.
- Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
- Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects.
- Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
- Demonstrates good working knowledge in pharmaceutics or combination regulatory requirements, 21 CFR 211 and ICH Quality Guidelines.
- Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team.
- Promotes and influences compliance with the client's quality, business and health & safety systems and market/legal regulations.
- Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines).
- Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group
- 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:
- 5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD
- Combination Products experience
- Able to work independently and communicate
If this job is a match for your background, we would be honoured 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. Let's talk!
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