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Quality Engineer

Kelly Services

Youngsville, NC
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Quality Engineer

Jobid US588YCS_BH1381882

Location: Youngsville, NC, 27596, USA



We are currently seeking a Quality Engineer in North Carolina to take on the responsiblity of joining a Cross Function Customer Focus team and assisting the QA Manager in the maintenance of the Quality Management System in the medical device industry. The person in this role will be responsible for assuring compliance with Quality System Procedures through the support of QA personnel.

Primary Duties and Responsibilities

• Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.

• Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.

• Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.

• Lead in the development and maintenance of Limit Samples and other inspection aids

• Lead all Risk Assessment activities

• Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner

• Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented

• Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.

• Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives

• Provide interface and communications with customer and suppliers on all quality concerns.

• Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices

• Review and approve Validation Protocols and Reports

• Assist in the execution of Validation activities as required.

• Interfaces with Suppliers regarding incoming quality issues

• Performs Supplier Audits

• Conducts Internal Audits

• Other duties as assigned

Required Qualifications

+ 4 year BS degree or equivalent applicable experience
+ At least 5 years experience in medical device manufacturing
+ Proficient in the use of Quality Management Tools
+ Proficient in MicroSoft Office Suite
Preferred Qualifications

+ ISO 9001 or ISO 13485 Certified Auditor
+ Experience in the performance of Supplier Audits / Evaluation
+ Experience in the appropriate selection of Statistical Tools
**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly 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 and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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