Quality Engineer I

Location: Sarasota, FL

Position Scope:

This position works collaboratively with the product development team to evaluate product designs for manufacturability.  The ideal candidate will be someone who has excellent interpersonal communication skills and eager to learn and grow with an innovative, medical device manufacturing company. They are a team player possessing initiative and self-motivation.

Specific Tactical Responsibilities:

  • Work cross-functionally to evaluate product design features and product functionality.
  • Analyze, trend, and summarize test and inspection data to identify product improvement
  • Evaluate product design features to determine appropriate tolerances, manufacturing requirements, measurement methods and acceptance criteria.
  • Investigate product failures, nonconformities and complaints utilizing data for product improvement.
  • Participate in validation activities including the preparation of validation protocols and validation reports.
  • Develop product specifications, procedures, work instructions and inspection plans to ensure product quality standards are achieved.
  • Assist with updating risk management files in accordance with ISO 14971 requirements and support the preparation of design documentation, as necessary.
  • Assist with employee training.

Job Complexity

Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Position requires someone with a keen interest and willingness to learn FDA, ISO and other regulatory guidelines related to the manufacturing of medical devices.

Supervisor Responsibilities:

None.  This is an individual contributor role.

Desired Experience, Knowledge and Skills:

  • College degree in mechanical engineering, biomedical engineering, or related field
  • Possess a working knowledge of statistical analysis
  • Able to review blueprints/models and measurement data to identify product design flaws
  • Solid writing and presentation skills
  • Experience with Minitab and Solid works or equivalent, desirable
  • Previous QE work experience in a regulated industry, desirable

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.