Kelly Services Quality Engineer in Shirley, Massachusetts
Kelly Services is seeking an Quality Engineer for our well-known client in the Medical Device industry in Shirley MA. The ideal candidate would have a Bachelors in Engineering and a few years of experience in quality assurance in a medical device Industry. This is a 12-month contract role with a possibility of converting into a permanent position
Title: Quality Engineer
Location: Shirley MA
Duration: 12 months (Contract to Hire)
As a Quality Engineer, you will serve as liaison between suppliers and Stryker to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation. You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
Work closely with operations and the business functions to ensure quality performance of product and processes.
Collaborate with Divisional QA, cross-functional and supplier teams to address top quality issues.
Participate in supplier performance reviews
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions.
Participate in CAPA projects and manage to timely root cause investigation, implementation and closure.
Lead internal and supplier driven non-conformances and manage the timely closure of NC's.
Apply statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes
Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers.
Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc).
Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
Deliver continuous improvement activities focusing on supplier quality.
Support the creation and maintenance of inspection methods and sampling.
Support the development and review of process and equipment validation/qualification and MSA of internal processes.
Support internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
Participate as required in SCRB in conjunction with key stakeholders.
Support assessment of supplier changes.
Participate in supplier reviews for assigned suppliers as required.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
Knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
Demonstrated working knowledge to positively influence supplier quality performance
Preferred industries are medical device, aviation, aerospace, automotive and defense
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
Transportation Spending Accounts
Offered and coordinated 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 ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.
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