23 days old

Supplier Quality Engineer (EU MDR)

Kelly Services
Portage, MI 49024
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ month, long term contract opportunity as a Supplier Quality Engineer (EU MDR) for a top fortune 500 company in Portage MI.

**Title:** Supplier Quality Engineer (EU MDR)

**Duration:** 12+ months

**Location:** Portage MI

**Essential Duties and Responsibilities:**

+ EU MDR is a new EU regulation which requires all Medical Devices to comply as per the required timelines.

+ Supplier Quality Lead role lies within the Supplier Workstream to support implementation activities Divisionally.

+ Remotely Lead indirect Quality Engineer reports based Globally

+ Report to the Program Manager escalations, risks and project status

+ Execute Global Project activities

+ Liaise with Sourcing partners

+ Support all activities required by Divisions to support the execution of EU MDR to meet deadlines

+ Provide support for all Supplier Quality related activities. Assist in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.

+ Ownership for supplier quality performance and measurement including KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews

+ Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions

+ 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

+ Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders

+ 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.

+ 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

+ Participate as required in SCRB in conjunction with key stakeholders

+ Support ECR process in local change control systems

+ Participate in supplier audit program planning, execution and closure

+ Participate in supplier reviews for assigned suppliers as required

+ Participate in cross functional projects both locally & globally as required

+ Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.


+ Technical understanding of manufacturing prints and tolerancing

+ Strong communication skills

+ Strong problem-solving skills

+ Strong team player

+ Good understanding and ability to work with Microsoft Office

+ Basic understanding of manufacturing processes

+ Fluent in written & oral English

+ Willing to travel in support of business needs to different geographical locations

+ Basic understanding of project management

+ Demonstrated interpersonal skills

**Education / Experience:**

+ Bachelors degree

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( ) for immediate consideration.

**Why Kelly?**

+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!

**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.
Posted: 2019-10-25 Expires: 2019-11-25

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Supplier Quality Engineer (EU MDR)

Kelly Services
Portage, MI 49024

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