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Sr Quality Assurance Engineer

Kelly Services

Milford, MA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Sr Quality Assurance Engineer

Jobid US588YAR_BH1446522

Location: Milford, MA, 01757, USA

Description **Quality Assurance Specialist III**

A market leader in In-vitro diagnostics is seeking a highly experienced quality assurance professional with a working knowledge of quality system requirements, including **FDA QSR/cGMP, ISO 13485 and ISO 14971** . The successful candidate will have a strong orientation toward root cause analysis, continuous improvement based on predictive and preventive metrics, and the ability to act as a role model, change agent, and mentor. The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance.


+ Bachelor’s Degree in a scientific discipline, or Associate’s Degree in a scientific discipline with at least 8 years’ **Quality Assurance experience in a serology, immuno-chemistry, and/or molecular biology work environment.**
+ A minimum of 5 years of experience working in a **cGMP or ISO 1348** 5 environment.
+ Extensive experience investigating quality issues and trends from c **ustomer complaints, NCMRs, CAPAs, etc. to identify actions required. Responsible for CAPA and Root Cause Analysis**

+ **Facilitate and lead cross functional teams in investigations of deviations, nonconformance’s, CAPAs, and product complaints to determine root cause and implement corrective actions to mitigate root cause** s; work constructively with functional groups to determine root causes for process issues related to products and services.
+ Ensure accurate QMS records related to **non-conformances, deviations, customer complaints and CAPAs** .
+ Investigate quality issues and trends from c **ustomer complaints, NCMRs, CAPAs, etc. to identify actions required.**
+ Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce risks to acceptable levels.
+ Review and approve Document Change Requests (DCRs) related to to materials, production processes, and test methods.
+ Support ongoing product release activities such as review of batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
+ Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
+ Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings.
+ Provide training and support for quality concepts and tools.

+ Root cause analysis expertise.
+ Focused on problem solving, including problem definition, risk evaluation, and risk-based resolution.
+ Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress.
+ Ability to track and complete multiple priorities in a dynamic environment.
+ Strong interpersonal, organizational, verbal and written communication skills.
+ Demonstrates curiosity, adaptability and commitment; works best in a team environment and actively seeks to foster relationships.
+ Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem solving process.
+ Oriented to continuous improvement with desire to balance the level of control and flexibility in systems based on risk.
+ Impeccable attention to detail.
+ Ability to manage multiple tasks and meet timelines with minimal supervision.
**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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