Job Title: Quality Engineer
Job Summary: The Quality Engineer is responsible for activities related to the quality and regulatory compliance to the Quality Management System and external medical device quality/regulatory bodies. The Quality Engineer plays a key role in the manufacture and distribution of the company’s products. This position reports directly to the Quality Manager.
- Develop, document and implement QA Procedures as needed.
- Responsible for products within a given therapy line (Design to Product Release)
- Ensures that suppliers deliver quality parts, materials, and services.
- Helps qualify suppliers according to company standards and may assist with supplier audits as needed.
- Maintains risk management files for products within a given therapy line
- Interpret and assess conformity to appropriate regulatory standards.
- Analyze non-conforming materials and returned goods and recommend disposition and corrective actions.
- Provide analytical investigations and develop root cause for non-conformances and deviations.
- Design and specify gauging and test equipment for quality assurance functions.
- Analyze data and generate summary reports.
- Independently develops qualification and validation protocols/reports.
- Collaborate with quality, production engineering and manufacturing teams to establish quality standards for new and existing products.
- Participates in design reviews, risk management, validations, CAPA’s, NCMR’s, etc.
- Assures the content of Design History File meets regulatory and company requirements.
- Develop and manage metrics for product reviews, quality management reviews, contract manufacturer oversight and other quality data.
- Support planning and execution of design verification, validation, and risk management reviews.
Education and Experience:
- BS or MS in Engineering, or scientific related fields.
- Medical Device industry experience required; preferably in vascular access.
- Experience working with remote suppliers and facilities, both domestic and international - preferred
- Certified Quality Auditor or Certified Biomedical Auditor (ASQ) – preferred.
- Clean Room experience – preferred.
Knowledge, Skills and Abilities:
- Travel up to 25%
- Knowledge of Sterilization: Ethylene Oxide & Gamma Radiation
- Ability to write routine reports and correspondence.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Must have a strong computer literacy.
- Expert understanding of GMP, quality systems, ISO 13485 and FDA QSR for medical devices, and Safety Risk Management ISO 14971
- Knowledge of Class II medical devices.