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15 days old

Supplier Quality Auditor

Kelly Services
Mahwah, NJ 07430
Kelly Services is seeking an **Supplier Quality Auditor** for our well-known client in the **Medical Device** industry in **Mahwah NJ** . The ideal candidate will have a Bachelors degree plus professional experience in 3 years of relevant experience in Quality, Management, or Engineering. **This is a 11-month contract role with possibility of extension**



**Title: Supplier Quality Auditor**



**Location: Mahwah NJ**



**Duration: 11 months**



**Job Description**



**Responsibilities related to compliance:**




+ Complete risk-based audits of suppliers per Strykers required cycle times to ensure conformance and compliance

+ Lead timely and compliant Operations audits as required and directed by the internal audit program

+ Provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations audits

+ Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements

+ Identify and write findings and observations during evaluations and drive timely closure of NCs through the CAPA system

+ Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations

+ Work with suppliers to quarantine all suspect and non-conforming material, as required

+ Issue supplier corrective action requests, as required, and drive suppliers to identify, correct, and prevent the root cause

+ Participate in supplier audits, supplier evaluation, and supplier monitoring as required

+ Train and educate suppliers on GMP, regulatory requirements, and Stryker expectations



**Responsibilities related to sustainment** :




+ Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements

+ Ensure a timely supply of conforming components and products to Stryker through process sustainment

+ Root cause analysis of processes related manufacturing defects and warranty concerns

+ Communicate results of supplier evaluations to Stryker stakeholders and suppliers to ensure adequate responsiveness

+ Identify and communicate supplier initiated changes and ensure the suppliers follow change control requirements

+ Serve as a subject matter expert for supplier evaluations, share expertise within the division and site

+ Support manufacturing transfer projects through the effective and efficient evaluation of suppliers and processes



**Responsibilities related to development:**




+ Foster strong relationships with Strykers supplier-partners acting as an extended enterprise

+ Complete on-site audits of suppliers Quality Management Systems through risk based processes audits

+ Drive improvement by identifying and communicating ineffective or inefficient Quality Management System processes

+ Report non-conformance and performance data to highlight systemic supplier issues

+ Support the creation and execution of supplier development plans by identifying potential process improvements

+ Drive continuous improvement actions within supplier processes to reduce part related defects (DMP)

+ Evaluate and qualify new suppliers and advanced technology processes to support product innovation

+ Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection

+ Partner with suppliers on Quality topics: Quality System, problem solving, validation, and lean

+ Communicate lessons learned from the supply base to R&D for incorporation into next generation designs Become recognized and trusted as a divisional and site auditor expert and resource



**Education and Experience**




+ 3 years of relevant experience in Quality, Management, or Engineering

+ Experience in medical device industry preferred

+ Experience working onsite developing suppliers preferred

+ Experience conducting supplier audits and internal audits preferred

+ Demonstrated collaboration, negotiation, and conflict resolution skills

+ Demonstrated ability to lead, champion change, and execute strategies to meet goals

+ Critical thinking and strong analytical skills

+ Comprehends production/process controls, FDA verification/validation, problem solving, & root cause

+ Comprehends quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts

+ Comprehends statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability





**Why Kelly?**



As a Kelly employee, youll 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.



**Apply Today!**




**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, 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.

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Posted: 2019-11-29 Expires: 2019-12-30

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Supplier Quality Auditor

Kelly Services
Mahwah, NJ 07430

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