16 days old

Sr Supplier Quality Engineer (Medical device)

Kelly Services
Sr Supplier Quality Engineer (Medical device)



6-12 months contract

The Sr. Supplier Quality Engineer serves a key role for supplier onboarding activities for both sustaining and merger & acquisition (M&A) quality support .

As a leader in achieving staggering growth through M&A and R&D, client continues to set the pace to successfully integrate and bring disruptive technologies to operating rooms all over the world, every day.

The Sr. Supplier Quality Engineer interfaces with many functions of the business, both internal and external, including suppliers, quality, sourcing, regulatory, and operations, ensuring that the products and services provided by our global supply base continue to meet and exceed customer needs.

Whether assessing supplier onboarding risks, evaluating suppliers of new or existing products, establishing agreements, or performing robust root cause investigations for NCs/CAPAs, the Sr. Supplier Quality Engineer is focused on building quality into the products we sell.

What you will do:

o Collaborates with suppliers to assure the quality of their products, materials, components and/or operations.

o Monitors supplier performance and supports efforts to develop and implement changes to improve the production process.

o Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented. o This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Key Areas of Responsibility:

o Collaborates with cross-functional and suppliers teams to address top quality issues.

o Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.

o Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

o Participates and may lead in the creation and/or review of new or modified procedures. o Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary. o Applies statistical methods of analysis and process control to external operations.

o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

o Can work remotely, 25% Domestic Travel o Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions

o Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers

o Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.

o 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. o Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.

o Deliver continuous improvement activities focusing on supplier quality.

o Participate in supplier audit program planning, execution and closure.

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

Basic Qualifications:

Bachelors Degree 3+ years' experience in quality, engineering, manufacturing, or highly regulated environment

The hard requirement is that the candidate must have an ISO9001/ISO13485 lead auditor certificate

Preferred Qualifications: Bachelors or Masters Degree in Engineering or Science-related field Fluent in written & oral English.

o Understanding of US, EU and International Medical Device Regulations. Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics). Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. Strong interpersonal skills, written, oral communication and negotiations skills. o Strong in critical thinking and "outside the box" thinking. Highly developed problem-solving skills. Strong analytical skills. Demonstrated ability to work independently and as part of cross-functional teams. o Experience in working in a compliance risk situation. o Computer literacy. Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards. o Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment. o Lead Quality Auditor Qualification either in ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements preferred. The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-05-28 Expires: 2021-06-28

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Sr Supplier Quality Engineer (Medical device)

Kelly Services

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