8 Jobs in maple, MN
Talent Software services is Hiring a Quality Engineer Near Maple, MN
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)
- 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
- 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
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
Full Time
IT Outsourcing & Consulting
$99k-117k (estimate)
06/27/2024
12/22/2024
talentemail.com
Minneapolis, MN
50 - 100
IT Outsourcing & Consulting
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The job skills required for Quality Engineer include Problem Solving, Written Communication, Consulting, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
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