Kelly Services Sr. Principal Software Quality Engineer in Deerfield, Illinois60015

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a Contract opportunity to work as Sr. Quality Principal Software Engineer in a prestigious Fortune 500® company located in Deerfield, IL.

Title: Sr. Principal Software Quality Engineer Duration: 6+ months Location: Deerfield, IL Shift: First Shift

We are looking for a Senior Principal Software Quality Engineer who works as a member of one or more project teams by being engaged in new product development and/ or sustaining products for medical device and/ or commercial systems.

This individual will serve as a quality representative on the software project team and will work closely with the Core Team Leader and is responsible for ensuring that each project is developed and released meeting customer expectations and regulatory requirements.

This individual will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer, change control management and will also provide support to product software sustaining engineering. Bachelor’s degree in Engineering or Computer Science plus 8-12 years of experience or MS Engineering with 5-7 years of experience or Ph.D. Engineering with 3-5 years of experience in a highly regulated industry such as FDA, DoD, aerospace, telecom, or nuclear with a thorough understanding of the regulations, standards, SDLC and quality management systems.

Knowledge/experience required:

• Design and Development Planning • Development of Technical Requirements and Product Specifications • Risk Management/ FMEA • Design Verification and Design Validation • Statistical Analysis • Design Reviews • Design Transfer Activities • Design History File Management • Complaint Management • CAPA and FCA

Candidate must have:

• Experience on a product development team releasing software product to market for a highly regulated industry. Medical device preferred • Thorough understanding of regulations, standards, guidance documents and best practices for software development in a highly regulated industry (Medical device preferred: specifically 21 CFR Parts 820, 803, & 806, ISO 13485, ISO 14971 and IEC 62304) • Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.) • Detailed knowledge of software development, quality assurance and verification and validation testing. • Thorough understanding to manage software issue/ complaint investigations, CAPA and FCA assessments. • In-depth understanding of software development lifecycle phases. • Experience with FDA inspections. ISO/ Notified Body audits is a plus • Ability to work at Senior Management levels. • Strong communication and leadership skills. • Strong, results driven, project management skills. • Excellent problem solving skills and the ability to teach others. • Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification within two years. ASQ CSQE preferred

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (kait815@kellyservices.com) however your resume must be received via the “submit now” button included within.

By working with Kelly in this role, you would be eligible for:

Kelly-sponsored Affordable Care Act health care coverage available to eligible employees Group insurance options* Service bonus plan Holiday pay plan Weekly electronic pay options Online training campus that provides more than 3,000 free courses to help improve and develop skills Exclusive online employee community Employee assistance program available at no cost Corporate discounts Transportation Spending Accounts *Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.

Why Kelly®? 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.

About Kelly Services®

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 2016 was $5.3 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.]]

Category: Biotech/Clinical/R&D/Science