myGwork - LGBTQ+ Business Community · 3 days ago

Validation Specialist

Lenexa, KS

Full-time

Onsite

Entry Level

1+ years exp

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Responsibilities

Complete Validation studies in compliance with 21CFR part 820, ISO 13485, and other medical device industry standards.

Implement the Validation Master Plan (VMP) for assigned area. Perform new qualifications and routine requalifications according to the VMP.

Collect samples and analyze data to evaluate equipment and process performance.

Set, incubate, and read microbial media test results. (Including bacterial indicators (BI), media fills, and utilities)

Perform investigations when abnormal results are found.

Support process investigations with validation data as needed.

Write reports and protocols to support qualification of new equipment and requalification.

Support Regulatory and Customer Audits.

Support continuous improvement activities and the transition to a Lean Manufacturing Environment.

Provide input to cross-functional teams to improve processes.

Partner with Engineering on installation and qualification of new equipment.

Qualification

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ValidationLean manufacturingQuality toolsMedical deviceGMPEU regulationISO 13485Data analysisExcelMini-tabProblem solvingTeamwork

Required

Bachelor's Degree in a science, engineering, or related field required.

1 -2 years of Validation experience in a regulated environment required.

Experience with lean manufacturing tools and practices.

Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments).

Background in Medical device, GMP, EU Regulation or ISO 13485.

Data analysis skills and ability to use computer programs to analyze data to drive decisions.

Ability to prioritize multiple tasks and function effectively.

Proven ability to work effectively as a member of a cross-functional team.

Solid understanding of various computer software, such as Excel, Mini-tab.