Validation Specialist

2 weeks ago

Marquand, Missouri, United States Kimball Electronics Full time
About the Role

We are seeking a highly skilled Validation Engineer to join our team at Kimball Electronics. As a Validation Engineer, you will play a critical role in ensuring the quality and safety of our medical device products.

Key Responsibilities
  • Develop and execute validation plans and protocols for all phases of the validation lifecycle
  • Execute test protocols and analyze data using statistical techniques, tools, and software
  • Schedule and host Validation Review meetings, reviewing and approving validation documentation
  • Allocate resources to support new or existing validation projects
  • Manage projects that may compete for your time while keeping accurate records of work
  • Demonstrate a solid understanding of the importance of quality and documentation
Requirements
  • 3-5 years' experience in Medical Device manufacturing
  • Bachelor's degree in Engineering or Engineering Technology (Mechanical, Electrical, Biomedical)
  • Knowledgeable on ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations
  • Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes, and packaging processes
Preferred Qualifications
  • Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & GR&Rs
  • Process development/characterization experience
  • Ability to analyze data through the use of statistical principles (e.g. process capability, normality test, GR&R, etc.) and statistical software (e.g. Minitab)
  • Ability to compose professional and engineering documentation (e.g. protocols, engineering studies, reports, etc.)
  • Ability to manage time and projects effectively while setting and meeting aggressive schedules
  • Quality-oriented individual with a focus on making data-driven decisions
  • Proficient with the use of Microsoft tools (Word, Excel, Project, PowerPoint, Visio)
  • Ability to understand business, legal, and regulatory requirements
What We Offer
  • 3 weeks of PTO starting your 1st year, in addition to 10 paid holidays
  • Annual profit-sharing bonus based on company performance
  • Major health, dental, vision, and complementary insurances starting day 1
  • 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually and you are vested 100% immediately
Kimball Electronics is an Equal Opportunity Employer

We are committed to building a diverse and inclusive work environment. If you think you might be a good fit for this role but don't necessarily meet every requirement, we encourage you to apply. We will consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition, or disability, or any other characteristic protected by applicable federal, state, or local law.

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