Post Market Surveillance Engineer

Post Market Surveillance Engineer

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Director, Post Market Surveillance

Description

Performs complaint product analysis and root cause investigation in support of Advita 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 Advita'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 Advita'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 Advita'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 Advita’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:

• Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred.

Experience:

• Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, root cause and risk analysis, and technical writing.
• Previous experience in the Medical Device or Pharmaceutical FDA regulated environment preferred.
• Experience with FDA/ISO quality management system regulations preferred.

Functional/Technical Knowledge, Skills and Abilities Required:

• Must have excellent communication (verbal & written) and organizational skills.
• Must have excellent interpersonal skills and must be able to work effectively in a team environment.
• Must be detail-oriented and have the ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform analyses with accuracy.
• Strong organizational and time management skills.
• Self-directed; capable of setting own priorities and working independently to meet established deadlines.
• Must be creative and have the ability to independently apply theoretical technical principles to product design.
• Must have knowledge of various software packages including Microsoft Office applications.
• To fully meet team responsibilities, the individual will develop additional knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.