{bc}
Apply
oracle

Senior Engineer, Quality

Otsuka ICU Med Careers
Indiana, USA
Full-time
Senior · 7+ years experience
Onsite
Discovered Yesterday

Full Job Posting

Knowledge & Skills

  • Expert quality compliance, audit, and investigation skills
  • In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
  • Strong knowledge of medical device standards, including but not limited to:
  • ISO 13485
  • ISO 14971
  • IEC 60601
  • IEC 62304
  • In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
  • Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
  • Proven ability to work closely with engineering teams and members of a cross functional team
  • New product development experience is strongly preferred.
  • Minimum Qualifications, Education & Experience
  • Must be at least 18 years of age
  • Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
  • Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry
  • ASQ CQE or CSQE required or the ability to obtain within one year.
  • Work Environment
  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel 5% to 10% of the time

Qualifications

  • Expert quality compliance, audit, and investigation skills
  • In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
  • ISO 13485
  • ISO 14971
  • IEC 60601
  • IEC 62304
  • In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
  • Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
  • Proven ability to work closely with engineering teams and members of a cross functional team
  • Minimum Qualifications, Education & Experience
  • Must be at least 18 years of age
  • Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
  • Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry
  • ASQ CQE or CSQE required or the ability to obtain within one year.
  • Work Environment
  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel 5% to 10% of the time

Preferred Qualifications

  • New product development experience is strongly preferred.

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Otsuka ICU Med Careers

Material Handler II

Salt Lake City, USA

Discovered TodayFull-time

Alternate Site Sales Specialist - Northwest

, USA

Discovered TodayFull-time

Senior Engineer, Quality

, USA

Discovered TodayFull-time

Supervisor, Manufacturing

Southington, USA

Discovered YesterdayFull-time

Device Sales Specialist - OK/KS/NE

, USA

Discovered YesterdayFull-time

Senior Specialist, Marketing Operations

, USA

Discovered YesterdayFull-time

Supervisor, Manufacturing

Southington, USA

Discovered YesterdayFull-time

Validation Engineer II

Austin, USA

Discovered 6 days agoFull-time