Senior Quality Engineer

PURPOSE:

Contribute to the project teams by reviewing prints, risk assessments, and quality planning. This includes communication with Engineering on inspection methods, materials, and suppliers.

GENERAL RESPONSIBILITIES:

  • Reviews proposed changes to determine if regulatory filings are required.
  • Approves Regulatory documents with respect to product quality.
  • Serve as a team member to provide quality assurance and risk management expertise to product development teams.
  • Maintain company compliance of FDA Quality System Regulations, ISO 13485 standard, the Medical Device Directive, and the Canadian Medical Device Regulations.
  • Conduct failure and hazard analysis for development projects.
  • Conduct internal quality and external supplier audits.
  • Performs receiving inspection & product release activities.
  • Assists in the company’s complaint and failure investigation process.
  • Manage test protocol & report development for validations.
  • All other duties as assigned.

SKILL AND EDUCATION REQUIREMENTS:

  • 5 years’ experience of Quality Engineering / Management in a medical device / biotech company / other regulated industry.
  • Bachelors of Science in Engineering or related technical field preferred, OR equivalent in experience and training.
  • In-depth knowledge of a quality system and ISO standards.
  • Knowledge of basic statistical and engineering principals is essential.

Interested parties should submit their resume via the form below.

You may also submit via mail to:

Nextremity Solutions
ATTN: Chris Cook
210 N. Buffalo St.
Warsaw, IN 46580
732-383-7901.