This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) product failure analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.
How you will make an impact:
Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
Participate in escalation tasks and activities, including Product Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
What you'll need (Required Qualifications):
Bachelor's Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Master’s degree in Engineering or Scientific field with either no experience (or internship experience).
Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
What else we look for (Preferred Qualifications):
Experience with medical devices and working under a medical device regulated environment
Complaints investigation experience and/or hands-on experience with device investigations
Demonstrated experience with risk management/risk assessments
Experience working in lab environment and familiarity with common measurement/test equipment (calipers, micrometers, pressure gages, leak testing, etc.)
Experience with data analysis and able to generate metrics for trending and review
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Knowledge of and adherence to Quality systems
Must be able to work in a team environment
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $87,000 to $123,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
