Quality Engineer, Post Market

What You'll Do

• Support complaint intake, triage, and classification in accordance with internal SOPs and applicable regulatory requirements
• Lead and document root cause investigations for reported complaints and adverse events, applying appropriate investigative methodologies
• Engage directly with surgeons, sales teams, and other field partners to gather clinical context, clarify product performance, and support timely root cause determination
• Determine reportability and prepare timely adverse event submissions to applicable competent authorities, including MDRs, MIRs, and equivalent global vigilance reports
• Author, contribute to, and review periodic post-market surveillance reports, including PSURs, Canadian Summary Reports, and other regional reporting requirements
• Perform trending analysis on complaint and adverse event data to identify emerging product performance signals and escalate findings as appropriate
• Support data requests related to Post-Market Health Risk Assessments (PMHRA), Product Field Action Assessments (PFAA), Product Historical Performance reports (PHP), country-specific requests, and other internal needs
• Support internal and external audits and inspections by providing documentation, data, and subject matter expertise related to post-market surveillance activities
• Maintain accurate and complete documentation within the complaint handling and quality management systems, ensuring traceability and audit readiness
• Provide mentoring and leadership to junior engineers
• Contribute to the development of new and improved quality processes and support process improvement initiatives that enhance the efficiency, consistency, and compliance of post-market surveillance activities

What You Bring

• Bachelor's degree in science, engineering, or a related technical field required
• 0-1 years of experience in a quality role within a medical device company
• Knowledge of Quality concepts (e.g., Risk Management, CAPA, Audits, Statistics)
• Strong interpersonal, written, oral communication, and negotiation skills
• Strong critical thinking, "outside the box" thinking, and highly developed problem-solving and analytical skills
• Demonstrated ability to work independently and participate effectively in cross-functional teams
• Computer literacy, including proficiency with Power BI, basic coding, or automations preferred
• Ability to read and interpret engineering drawings and other technical specifications preferred

Compensation

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $80,000.00 - $88,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.

Benefits include

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company