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Sr. Quality Systems Engineer

Kelly Services

Shoreview, MN
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Sr. Quality Systems Engineer

Jobid US41ALRR_BH1419026

Location: Shoreview, MN, 55126, USA

Description Kelly Services is currently looking to hire a **Sr. Quality Systems Engineer** to work for one of our top Med Device customers in Shoreview, MN

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States. We are unable to sponsor at this time.

**Position Summary:**

The Sr. Quality Systems Engineer is responsible for developing and maintaining quality engineering systems in support of internal initiatives and changing external requirements.

These activities may include audit responses, internal continuous improvements, or required quality system changes based on standards changes.

SQE will work directly with internal and external customers to ensure quality system requirements are met.

SQE is responsible for following applicable quality system practices and completing all specific training requirements.

**Position Responsibilities:**

Assist in gap analysis to quality system standards or best practices Define, refine, and carry out the Quality System policies and systemic improvements.

Complete necessary training to be educated in changing regulatory quality system requirements.

Train employees relevant to quality system initiatives.

Document project plans and execute through the document control system planned improvements.

Support audits of quality systems and resulting action items Lead execution of document control related processes.

Lead execution of document control related processes.

**Education and Work Experience:**

Bachelor s Degree in Engineering or Engineering technology; other technical degrees or equivalent - occupational experience may be considered.

**Qualified candidate must possess:**

Quality Systems Engineering experience; preferably 5+ year’s medical device or other regulated industry.

Technical understanding with the ability to analyze information

Engineering experience and demonstrated use of Quality tools/methodologies

Detailed knowledge of FDA, GMP, ISO 13485, MDD/MDR, preferably from Med Device, Pharma, Military, Manufacturing or Electronics Industries.

**Specialized Knowledge and Skills:**

Project management encompassing self-directed, highly organized and results-oriented skills with the ability to work with internal cross-functional teams and external clients in a fast-pace, emerging growth organization Exceptional time management meeting corporate and departmental objectives.

Ability to interpret and analyze complex/detailed data Good interpersonal skills with the ability to resolve problematic issues quickly and efficiently.

**Equipment and Applications:**

Proficient/advanced Microsoft Suite computer skills utilizing Word, Excel, PowerPoint, and Outlook


**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly 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 2017 was $5.4 billion. Visit 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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