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Senior Supplier Quality Engineer

Kelly Engineering Resources St. Louis Full-Time
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Contract opportunity

JOB TITLE

Senior Supplier Quality Engineer

OBJECTIVES/
PURPOSE OF JOB

Responsible for Supplier Quality Assurance of new product designs and product line extensions led by Research and Development at the surgical business unit including, but not limited to: product sourcing decision support; advanced product quality planning; supplier’s assessment and qualification; validation of supplier processes; qualification of parts and/or finished products; and concern resolution process leadership.

Additionally, it may function in the same capacity to support maintenance of business (MOB) projects and cost improvement (CIP) projects.

KEY ACTIVITIES/
RESPONSIBILITIES

Represent Supplier Quality in internal project meetings and manufacturing readiness reviews, and leads supplier on multiple Quality deliverables during qualification phases.

Acts as the Supplier Quality liaison between Manufacturing, R&D Engineering, Purchasing, Operations Quality, and the supplier.

Supports purchasing and R&D with source identification, evaluation and selection. Leads On-Site Assessments and supplier questionnaires of potential suppliers.

Assists R&D and the project team in the definition of critical product characteristics, and provides feedback on design manufacturability assessments to ensure a successful design transfer with robust specifications to suppliers.

Coordinates supplier activities necessary to fulfill B+L general and specific requirements for product qualification such as First Article Inspection, receiving inspection processes, supplier process controls, capability studies for critical product characteristics and implementation of PFMEAs and Control Plans, process validation, among others.

Develop and maintain local supplier management procedures to ensure that regulatory, local and corporate requirements are met. Review and provide input to new/revised corporate procedures that impact the site.

Perform supplier audits for new suppliers to assure products/services meet the requirements of applicable ISO standards, regulations, product specifications and B+L local and corporate requirements.

Responsibilities may include up to 15% travel.

Reviews receiving inspection results and verify first receipt is accepted.

Reviews and approves supplier-related Change Notices and documentation for new products and/or services.

Ensures resolution of supplier related quality problems, including internal failures, customer complaints and audit findings by managing nonconforming product disposition, supplier investigation of root cause, corrective action planning, implementation, and verification of effectiveness.

Establishes, reports, and sustains key supplier quality performance metrics and corresponding training, improvements and reporting responsibilities.

Ensure supplier documentation is maintained including risk assessments, quality agreements, and quality system certifications.

Supports costs of quality reduction goals and supplier risk mitigation activities.

Authoring, reviewing and implementation of policies and procedures, to drive supplier quality improvement processes for continuous improvement.

SUPERVISE DIRECT REPORTS

(yes or no)

No

SCOPE OF POSITION

The scope of the position is primarily focused on suppliers for new products with extended scope to support supplier quality issues affecting current operations.

KEY RELATIONSHIPS

Internal customers/business partners:

-Potential and current suppliers

-Research and Development

-Purchasing

-Regulatory Affairs

-Operations

-Manufacturing Engineering

-Global Quality

QUALIFICATIONS/
TRAINING

Required Education:

BS in Business, Biology, Chemistry, Engineering or Pharmacy (or equivalent experience)

Preference given to degreed engineers or technical degree type.

Required Skills/Qualifications:

Excellent verbal and written communication skills.  Ability to prioritize multiple tasks and projects with limited direct supervision.  Effective organization and negotiation skills.  Strong ability to manage suppliers, follow-up and complete projects.  Proficient in MS Office Applications

Special Training:

Required - Demonstrated hands on supplier management experience at FDA and ISO Regulated environment.

Required Experience:

5+ years’ Quality experience in the Medical Device Manufacturing industry; 3+ years in supplier quality related processes. Must have proven and results-driven track record of successfully managing projects, people and suppliers. Responsible for developing & implementing quality processes in a global business environment, including supplier manufacturing sites.

Preferred Experience:

Additional consideration for experience in other highly regulated industries (automotive, aerospace, etc.) and for the following certifications:  ASQ CQE, CQA, CQM and Six Sigma Green Belts, Black Belts, and Master Black Belts.



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 2017 was $5.4 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

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. URL blocked - click to apply

 

Recommended skills

Operations
Certified Quality Auditor
Certified Quality Engineer
(American Society For Quality) Asq Certified
Management
Corrective And Preventive Actions
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In a recent study, one-third of large companies predicted contingent workforce growth of 50 percent or more.* Kelly Engineering Resources® can help you be a part of this contingent workforce growth opportunity.

Kelly Engineering Resources, a specialty service of Kelly Services®, is focused exclusively on placing skilled engineering professionals in contract, contract-to-hire, and full-time engineering jobs across a full spectrum of related industries and disciplines, including:


  • Aeronautical
  • Environmental
  • Pharmaceutical
  • Chemical
  • Industrial
  • Quality
  • Civil/Structural
  • Mechanical
  • Telecommunications
  • Electrical/Instrumentation
  • Petroleum

Kelly Engineering Resources employees work more than 6 million hours in positions ranging from chemical engineers to robotic technicians to R&D specialists to AutoCAD® designers.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year.

Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices.

Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

*According to “The Emerging New Workforce,” a 2009 report by Littler Mendelson, P.C., an employment and Labor Law solution firm.

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