Validation Engineer

3 weeks ago

United PA USA, United States Oberg Industries Full time
Job Title: Validation Engineer

Oberg Industries is seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and safety of our medical devices. Your primary responsibility will be to develop, execute, and document validation protocols for our production processes, equipment, and systems.

Key Responsibilities:
  • Develop and execute validation protocols for cutting-edge medical device manufacturing processes, equipment, and systems.
  • Conduct risk assessments and ensure that critical process parameters are identified, tested, and validated.
  • Collaborate with cross-functional teams to ensure product and process validations meet regulatory and customer requirements.
  • Write and review validation reports, ensuring that all required data is accurately captured and meets the required standards.
  • Support process improvements by performing validation gap assessments and implementing corrective actions as needed.
  • Ensure timely completion of validation activities in alignment with project timelines.
  • Maintain compliance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).
  • Develop, execute, and maintain validation master plans.
  • Support internal and external audits by providing validation documentation and addressing auditor inquiries.
Requirements:
  • Experience working in the quality field, preferably as a Quality Engineer with either a medical device company or medical device contract manufacturer and/or a four-year college degree.
  • Experience working in ISO13485 / 21 CFR Part 820 or related quality system environment is required.
  • Experience with First Articles, Failure Modes and Effects Analysis (FMEA), Production Part Approval Process (PPAP) is preferred.
  • Experience with statistical analysis and SPC software programs is preferred (Minitab, QC Calc, etc.).
  • Experience with precision measurement equipment, such as drop gauges or surface analyzers, Coordinate Measuring Machines (CMMs), OGPs is preferred.
  • Internal auditing/supplier auditing experience preferred.
  • Working knowledge of FDA's Process Validation requirements and methods, (IQ, OQ, PQ)
  • Working knowledge of APQP concepts and tools.
  • Working knowledge of computer programs such as MS Excel, Access, Word, PowerPoint, etc.
  • Must have good oral and written communication skills and have a keen attention to detail.
  • Must be able to travel domestically and internationally.
  • Must be a U.S. citizen or be able to comply with U.S. export regulations.
  • Must be able to wear personal protective equipment such as earplugs, safety glasses, and safety shoes.
Benefits:
  • Competitive Pay
  • Medical, Dental and Vision Insurance (no premiums paid)
  • Medical benefit opt-out with Reimbursement option.
  • Health Savings Account (HAS)
  • Short & Long Term Disability (company paid, no contribution)
  • Death Benefit
  • 401K Retirement Plan (with 4% employer match)
  • Employer Profit Sharing program
  • Quarterly Bonus Program (based on company performance)
  • Paid Time Off (earning up to 5 weeks)
  • 9 Paid Holidays
  • Temperature-Controlled Work Environment

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