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- St. Louis, MO 63122
- Joe Tate
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Kelly Services: Sr Software Quality Specialist at Bausch & Lomb - Long Term
Kelly Engineering Resources • St. Louis, MO
Posted 2 months ago
Kelly Services, Inc. is happy to exclusively present a contract opportunity for a full time & long-term role as a Sr Software Quality Engineer at Bausch & Lomb in St Louis, MO The Details:
- Do you have around 5 years experience in the field of software with at around 3 years of hands on experience in a Quality role supporting a product design?
- This contract position is located onsite in St Louis, MO USA at Bausch & Lomb.
- M-F 8am-5pm!!
GREAT SALARY : VERY Negotiable based on experience!
- LET’S talk-apply for interview NOW!
The Sr. Software Quality Engineer has a responsibility to ensure Quality and Compliance, and provide overall Quality guidance during software development and validation of embedded software in the surgical devices. Day to Day Job Activity:
- Reviews and approves design and development planning documents and design change requests.
- Reviews and approves product requirements, system requirements, software requirements specifications, software architecture specifications, software detailed designs requirements using requirements traceability analysis.
- Reviews and approves Risk Management documentation.
- Review and approve Software Integration Test, Software System 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 software development team in risk management.
- Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that embedded software will accomplish design 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.
Key Bausch & Lomb Relationships:
- R&D Engineering
- Project and Program Management
- Regulatory Affairs
- Supplier Quality
- Bachelor Degree in Computer Science, Computer Engineering, or Software Engineering
Skills & Attributes Needed:
- 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
- 5+ years in the field of software with at least 3 years of hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, approval and release of embedded software in medical devices hardware.
- Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products.
- Proven record supporting the development and execution of software 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 Software Validation
- Former experience as a software developer using C, C++, C#, APIs, or equivalent.
- Worked with teams on 510(k) submissions and/or PMAS.
- We appreciate all our applicants, but we are not able to sponsor at this time; no C2C or H-1B.
- There is no ‘per diem’ with this position, and must be able to work on W-2 hourly basis.
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
This role is supported by the Kelly Services GTS – Recruiting and Sourcing division. Engineer, Specialist
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.