1+ months

Quality Engineer

Kelly Engineering Resources
Hopkinton, MA 01748
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  • Job Code
Product Quality Engineering (PQE)

Location: REMOTE (prefer east coast hours), can be flexible on the hours in the work schedule though (need to be day time hours)

Duration: 6 weeks duration. 40 hours/week for a 6 week duration, will consider candidates for 20 hours/week part for a 12 week duration.

Job Summary
Provide quality support for product Lifecyle management. Responsible for development activities of medical device products following design transfer requirements and internal procedures. Provides general engineering services and support for product manufacturing and quality control. The PQE is provided limited direction from the Manager to maintain the complaint and investigation processes and is capable of performing all activities and takes a leadership role with projects and product support.

Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
- Facilitate and actively contribute to the risk management activities per ISO 14971:2019: Risk Management Plans, pFMEA’s, Risk Control, etc. for new and released products.
- Supports nonconformance investigation, disposition and release activity as applicable
- Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
- Assists with the review of complaints to determine potential adverse events
- Assists with the department metrics and works with others to ensure department goals are achieved.
- Remediation of product documentation for changes in product compliance for new or updated regulations (i.e., MDR, IVDR)
- Identify, investigate and implement corrective and preventive actions (CAPAs)
- Participate/Lead projects related to Design Transfers
- Review technical product documentation including device master records (DMRs), drawings, bills of materials, test protocols and reports, manufacturing work instructions, engineering change orders (ECO), etc.
- Work with manufacturing engineer/process engineer to ensure process controls are in place
- Review and/or approve reports for: test method validations, design transfer, pilot production, and process validations (IQ, OQ, PQ).
- Write, review and / or approved quality plans to support product activities both internal and external.
- Assist in external & internal audits.
- Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

- Bachelor’s degree or higher in related disipline. Relevant work experience may offset the educational requirement.
- Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus

- 7+ years of experience as a Quality Professional in the Medical Device industry desired.

- Knowledge of ISO 13485 and ISO 9001 is essential as well as FDA and cGMP regulations and documentation practices
- Knowledge of Risk Management and applicable standards

Why Kelly?

As a Kelly employee, you’ll have access to premier perks, including:

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
Outstanding online employee community Corporate discounts

Transportation Spending Accounts
Offered and coordinated by Leslie & Associates. These plans are not sponsored by Kelly Services.

Why Kelly®?
As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.#KellyGTS]]
Posted: 2020-07-17 Expires: 2020-12-10
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Quality Engineer

Kelly Engineering Resources
Hopkinton, MA 01748

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