Be an early applicantLess than 25 applicants

Company

Original Job Post

Katalyst HealthCares & Life Sciences · 2 days ago

Quality Engineer

Mount Olive, NJ

Full-time

Onsite

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

AnalyticsBiopharma

H1B Sponsorship

Comp. & Benefits

Insider Connection @Katalyst HealthCares & Life Sciences

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

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

Participate 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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Process ValidationTMVProtocol DevelopmentISO 13485FDA QSRRisk ManagementDesign ControlsDesign TransferChange ControlProduct TransfersNew Product DevelopmentCAPA InvestigationsMedical Device IndustryRegulatory ComplianceMicrosoft ExcelPivot TablesStatistical AnalysisMinitabCertified Quality Engineer (CQE)Quality EngineeringProblem SolvingLeadershipOrganizational SkillsPrioritizationCommunicationSix Sigma Certification

Required

In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support 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 medical device or regulated industry

Proficient with Microsoft Excel, including use of pivot tables

Perform statistical analysis using standard software such as Minitab

Ability to make decisions and communicate effectively to multiple levels

Bachelor's degree in science or engineering field of study

Certified Quality Engineer (CQE)

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

Preferred

Six Sigma Certification experience

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)