149 applicants

Company

Original Job Post

Katalyst HealthCares & Life Sciences · 2 days ago

Quality Engineer

Flanders, NJ

Contract

Onsite

Senior Level

5+ years exp

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Comp. & Benefits

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Responsibilities

This position will be responsible for being the Quality Assurance lead for Validation as well as supporting Design Transfer and other change projects, including engineering and process change projects.

Support validation process through protocol drafting, approval, and execution and providing validation training and guidance.

Chair Process Change Review Board and participate in Validation Review Board meetings.

Participated in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead.

Lead improvement initiatives for Quality Assurance.

Independently perform full range of standard work.

Identify and resolve more complex problems and apply problems-solving skills to handle most situations.

Use statistical analysis and risk management techniques.

Provide guidance for process changes, including guidance on validation requirements.

Lead CAPA investigations.

In-depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with the ability to develop and support the creation of protocols and reports.

Proven ability to lead projects.

In-depth knowledge of requirements related to ISO 13485 and FDA QSR.

Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control.

Experience with product transfers and new product development projects.

Experience with problem-solving techniques and CAPA investigations.

Strong organizational skills and ability to prioritize.

Experience working in the medical device or regulated industry.

Proficient with Microsoft Excel, including the use of pivot tables.

Perform statistical analysis using standard software such as Minitab.

Ability to make decisions and communicate effectively at multiple levels.

Qualification

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Certified Quality EngineerSix Sigma CertificationMedical DeviceQuality Engineering

Required

Bachelor's degree in science or engineering field of study

Certified Quality Engineer (CQE) Six Sigma Certification experience preferred

5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above

Company

Katalyst HealthCares & Life Sciences

Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

H1B Sponsorship

Katalyst HealthCares & Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (20)

2022 (46)

2021 (43)

2020 (53)