Validation Engineer

Validation Engineer Needed For Leading Medical Device Manufacturer This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $100,000 - $110,000 per year A bit about us: My client is a leading medical device manufacturing company and is growing! They are looking to add a Validation Engineer who will be responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP). Why join us? Compensation Up To $110,000 Other Benefits Include Medical, Dental and Vision 401 (k) with company match Holiday, Vacation and Personal Time Off Tuition Reimbursement Employee Assistance Program (EAP) Short Term Disability Group Life and Accidental Insurance Job Details Responsibilities: Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols Works independently, taking lead on PPAP / Validation Completion. Leads team to provide deliverables, and takes initiative to proactively management the PPAP Process, including all applicable APQP documentation. Responsible for SOP and Technical Writing for New Programs Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Represent the customer in order to ensure that the customer’s quality expectations are clearly understood and being met. Support Program Management team on launch and management of medical device programs. Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s. Ability to participate in product design (R&D) meetings with Medical Customers in relationship with understanding key quality deliverables. Requirements: Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical device/life science (GxP) industry required. Requires a 4-yr engineering degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred. Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required. Ability to uses Minitab preferred. Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable. Knowledge of GMP/ISO/21 CFR 820 Quality Systems required. Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable. Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy