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7 days old

Design Quality Engineer II- DIRECT HIRE!!!!

Kelly Services
St Louis, MO 63103
**Design Quality Engineer II**


**DIRECT HIRE!!!!**


**St. Louis, MO Tree Court**


**OBJECTIVES/PURPOSE OF JOB**


Responsible to assure Quality and Compliance, and provide overall Quality guidance during the development and validation of surgical devices.


**KEY ACTIVITIES/RESPONSIBILITIES**


- Reviews and approves design and development planning documents and design change requests.


- Reviews and approves Risk Management documentation.


- Review and approve Test and Design Validation Test protocols and reports.


- Reviews and approvals ensure document deliverables with internal directives and SOPs and external industry standards and regulations.


- Influence the requirements definition and software design to maximize quality of requirements.


- Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing, and anomalies tracking for resolution.


- Work closely with the quality and development team in risk management.


- Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that the design will accomplish goals for a particular product.


- Help guide R&D teams through Quality Management System to ensure software is developed in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.


**SCOPE OF POSITION**


Scope of the referenced key activities and responsibilities is primarily project-based, with extended scope for the development and/or update of procedures, work instructions, forms and templates required to execute this role.


**KEY RELATIONSHIPS**


Internal customers/business partners:


- R&D Engineering


- Project and Program Management


- Regulatory Affairs


- Supplier Quality


**QUALIFICATIONS/TRAINING**


**Required Education:**


- Bachelor Degree in Engineering; Biomedical, Mechanical, Electrical, or Software.


**Required Skills/Qualifications:**


- Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software.


- Deep knowledge of embedded software testing


- Excellent analytical, problem solving, organizational, and communication skills


**Preferred Skills/Qualifications:**


**Required Experience:**


3 years in the field with hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, and approval.


Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device in FDA regulated products.


Proven record supporting the development and execution of V&V test protocols for complex medical devices.


Familiarity with EN 62304, EN ISO 14971, EN 62366, FDA regulations and international standards applicable to medical device design, development, verification and validation.


Working knowledge of FDA guidance for Medical Device V&V; packaging, transit, sterilization, product development, and the like.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-05-13 Expires: 2022-06-20

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Design Quality Engineer II- DIRECT HIRE!!!!

Kelly Services
St Louis, MO 63103

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