29 days old

Quality Engineer

Kelly Services
Huntingdon Valley, PA 19006
**Quality Engineer**

Kelly Science & Clinical is looking for a Quality Engineer for a **direct hire** opportunity with a biomedical company in Huntingdon Valley, Pennsylvania. The Quality Engineer works cross-functionally within QA and other departments to maintain compliance with the regulatory and quality system requirements including FDA, QSR, and ISO 13485. Responsible for coordinating supplier qualification and verifying quality standards in accordance with FDA, ISO, MSBUS requirements and other regulations.

**Salary: $85,000 plus bonus potential**

**Essential Functions**

+ Maintain Supplier Quality Files including Supplier Qualifications, Questionnaires, Supplier Certifications and Quality Agreements.

+ Track and qualify or disqualify suppliers according to MSBUS standards.

+ Report supplier performance and quality to management.

+ Identify technical problems with suppliers and support the implementation of corrective actions.

+ Support and assist in the selection of new supplier process as needed.

+ Maintain and update Approved Suppliers List (ASL) as needed.

+ Support the development of new Quality Agreements working and coordinating with External Manufacturing and Supplier representatives to obtain final approval and proper implementation

+ Draft and develop new SOPs and revise/update existing SOPs as needed.

+ Support and conduct Internal and Supplier Audits.

+ Support the Complaint handling process working with Quality Management ensuring the complaints are properly entered into the system in a timely manner including the accuracy and completeness of records.

+ Work closely with domestic and international service/complaint handling organizations, Field Service Engineers and company SMEs to gather more information to resolve open issues.

+ Identify and escalate emerging quality issues, potential risks, and trends including PHS events requiring further investigation and review by Regulatory Affairs.

+ Utilize Documentum for managing new documents and revisions to existing documents.

+ Manage and document significant supplier related issues in Trackwise where required.

+ Support and generate quality trend data from supplier audits and non-conformances and complaints for use in periodic updates and as part of the scheduled management reviews or in support of other objectives.

+ Support and actively participate in third party audit and regulatory inspection activities.

+ Support functional requirements for Deviations and non-conformances, change controls and CAPAs within Trackwise.

+ Support field actions/recalls as necessary.

+ Support process and design validation activities partnering with Validation Specialist, QC, Operations, R&D and third parties.

**General Competencies**

+ Technical acumen

+ Strong problem solving/analytical skills

+ Thoroughness and detail-oriented

+ Excellent Written/Verbal communication skills

+ Demonstrates prioritization and time management skills

+ Must be able to work independently and effectively as part of a team exhibiting effective interpersonal skills.

**Required Education and Experience**

+ Bachelors degree or two-year associates degree with relevant experience.

+ Minimum of 3 to 5 years of experience in a medical device or regulated industry.

+ Basic understanding of Supplier Quality functions including Supplier Audits, CAPA, Deviations/Non-conformances.

+ Management and/or experience in conducting Internal Audits and Supplier Audits.

+ Certification as an Internal Auditor is preferred.

+ Familiar with medical device regulations, requirements, and standards such as 21 CFR Parts 820 and ISO 13485.

+ Proficient with Microsoft Office.

+ Fundamental understanding of quality methods, tools, and concepts.

+ Experience working with electronic Quality System management and Document Management tools such as Trackwise and Documentum.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2022-04-22 Expires: 2022-05-23

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Quality Engineer

Kelly Services
Huntingdon Valley, PA 19006

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