Qa director serp_jobs.h1.location_city

QA Post Market Engineer

Performs complaint product analysis and root cause investigation in support of Exactech and regulatory requirements, product improvement, and issue escalation.

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.
• Know and applying Exactech's Quality System and any appropriate FDA and international standards
• Assist and support other employees, teams, and sales personnel as necessary.

Skills Knowledge and Expertise

Education :

Experience :

Functional / Technical Knowledge, Skills and Abilities Required :

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific.

Our Hiring Process

Stage 1 : Initial Interview

Stage 2 : Hiring Manager and Team Interview(s)

Stage 3 : Final Selection

Stage 4 : Offer