Medical Device Quality Engineer Job at Omni One, Columbus, OH

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  • Omni One
  • Columbus, OH

Job Description

Job Description

Medical Device Quality Engineer

Columbus, OH

$90,000 - $110,000

28872

Our client is a successful manufacturer who has continued to grow and expand their central Ohio footprint. They are currently searching for a talented Quality Engineer. This is a full-time/direct hire opening. They were founded in the early 1900’s and have grown to be the industry leader for products that help people every day.

  • Why Apply:Tremendous job stability
  • Awesome opportunity for growth and career achievement
  • Tremendous benefits including great match on 401(k), no vesting period for 401(k), onsite gymnasium, low-cost/great coverage insurance, and more

  • The current opening is for a Quality Engineer. Main duties include:Ensure quality and regulatory requirements are met for all Company products
  • Maintain QMS records for ISO 13485 and medical device regulations
  • Perform root-cause analysis and implement corrective actions
  • Perform internal, external, and FDA audits
  • Equipment validation, IQ/OQ/PQ
  • Implement risk management procedures
  • Create and implement processes for increased efficiency and effectiveness
  • Support long-term quality, regulatory, and compliance policies

  • Qualifications include:B.S. degree in an engineering discipline preferred
  • Minimum of 3+ years of experience required in an ISO 13485 and FDA regulated medical device industry
  • Ability to travel approximately 10-15% of the time to other facility locations
  • Must have a high level of attention to detail, accuracy, organization
  • Strong analytical and problem-solving skills
  • ASQ certification preferred
  • Excellent communication skills both verbal and written

Please apply or send us a copy of your resume to dublin@omnione.com. All of your information will be kept confidential. Please feel free to call us at 614-760-5799.

Applications that fit the listed requirements will be contacted within 2-3 business days to schedule an initial phone interview with the Omni One team.

Job Tags

Full time,

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