Product Quality Engineer

Job Title: Product Quality Engineer

Location: Marlborough, MA 01752

Duration: 5 Months

Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred

Organizational Relationships: Works with Divisional personnel and Costa Rica personnel including Product Quality Engineering (PQE), Post Market Quality Engineering (PMQE), and Post Market Analytics.

Job Summary

• Provide Product Quality Engineering support on risk management and product complaint trending. This role will be responsible for reviewing each complaint record individually and identifying the appropriate risk lines and associated severities from the product's Risk Management File (RMF) that relate to what was reported by the complainant and the results of the investigation. In partnership with Product Quality Engineering and Post Market Quality Engineering, the qualified contractor will perform assessments, identify potential updates to the RMF, and perform trend analysis per the applicable quality procedures.

Essential Duties

Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

Analyze complaint information and identify hazardous situations and harms reported through complaint information

Evaluating content in existing Risk Management Files ensuring all hazardous situations and harms reported through complaint information is adequately captured.

Perform trend analysis using Statistical Process Controls per applicable quality procedures.

Qualifications

-Education

• BS in biomedical engineering, mechanical engineering, or health care related disciplin

-Experience

Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred

- Skills

Experienced with Quality System Regulations, ISO 13485 and 21 CFR 820.

Experienced with ISO 14971, Risk Management

Basic knowledge of risk analysis techniques such as FMEAs

Basic knowledge of medical terminology and anatomy

Basic knowledge of engineering and process terminology

Understanding of statistics including statistical process control (SPC) - Minitab experience preferred

Detail-oriented and committed to maintaining accuracy and compliance in all tasks

Accountable and reliable, with a focus on timely communication and issue escalation

Collaborative team player, open to receiving feedback and contributing to shared goal

Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution

Ability to appropriately assess written product and project documentation, and ability to effectively communicate assessment

- Preferred

Experience authoring and executing risk assessments

Working knowledge of ISO14971, 21 CFR 803 and 21 CFR 820