QA Post Market Engineer Quality

Key Responsibilities

• Applies sound engineering problem-solving techniques during complaint investigation activities
• Performs complaint product analysis and testing per Exactech's procedures and requirements.
• Performs complaint root cause analysis.
• Performs complaint risk analysis and complaint history reviews.
• Escalates complaint investigation findings, as appropriate and per Exactech's procedures and requirements.
• Collaborates with cross-functional engineering teams to ensure thorough investigations and appropriate escalations.
• Documents all complaint investigation and escalation activities per Exactech's procedures and requirements.
• Provides design, engineering, and analysis support to other engineers and designers in the maintenance of orthopedic implants and instruments currently on the market as part of continuous improvement.
• Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
• Supports the completion of complaint activities in line with department metrics and key performance indicators.
• Supports audits and audit requests for complaints.
• Drafts investigation responses to customers, as requested.
• Supports the drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
• Supports continuous improvement activities.
• Assists in training complaint team members.
• Knowing and applying Exactech’s Quality System and any appropriate FDA and international standards.
• Assist and support other employees, teams, and sales personnel as necessary.