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Quality Engineer at Talent Software Services
Maple Grove, MN
About the Job
Quality Engineer
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN(Hybrid). The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life. Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems (MEE) within the Interventional Cardiology (IC) division. This person will be helping with sustainment of CAPA work and solutions - on development side.
Primary Responsibilities/Accountabilities:
Qualifications:
Preferred:
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. Let's talk!
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN(Hybrid). The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life. Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems (MEE) within the Interventional Cardiology (IC) division. This person will be helping with sustainment of CAPA work and solutions - on development side.
Primary Responsibilities/Accountabilities:
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
- Act as an effective team member in supporting quality disciplines, decisions, and practices
- Work within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk management
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Perform regulatory standard assessments and support regulatory submissions to notified bodies
- Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
- Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
Qualifications:
- Bachelor's degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
- Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
- Demonstrated use of Quality tools/methodologies
- Strong verbal and written communication skills
- Self-motivated with a passion for solving problems and a bias for action
- Effectively work and collaborate in a hybrid (onsite plus remote) environment
Preferred:
- Prior medical device industry experience, particularly with medical electrical equipment
- Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
- Experience in managing multiple projects across multiple organizational disciplines
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. Let's talk!
Salary
35 - 40 /hour