Quality Manager

Quality Manager

PURPOSE:

Manage the Quality Management

PURPOSE:

Manage the Quality Management System and 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:

  • 7-10 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.