Senior Software Quality Engineer
Medtronic
Cyber SecurityDockerLinuxPythonQt
QA Post-Market Engineer
Exactech
full-time
Posted on:
Location: Florida • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Performs complaint product analysis and root cause investigation in support of Exactech and regulatory requirements, product improvement, and issue escalation.
- 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 maintenance of orthopedic implants and instruments as part of continuous improvement.
- Supports CAPAs, HHEs, NCRs, and other quality processes, as needed.
- Supports completion of complaint activities in line with department metrics and KPIs.
- Supports audits and audit requests for complaints.
- Drafts investigation responses to customers, as requested.
- Supports drafting and revision of procedures, work instructions, forms, technical documents, and protocols.
- Supports continuous improvement activities and assists in training complaint team members.
- Know and apply Exactech’s Quality System and appropriate FDA and international standards.
- Assist and support other employees, teams, and sales personnel as necessary.
Requirements
- Bachelor’s Degree in an Engineering discipline from an accredited institution required; degree in Mechanical or Biomedical Engineering, or a Master’s Degree preferred.
- Must have a basic understanding of theoretical technical principles: 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.
- Must have excellent communication (verbal & written) and organizational skills.
- Must have excellent interpersonal skills and ability to work effectively in a team environment.
- Must be detail-oriented with high standards of input accuracy, document quality, and data/analysis 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 able to independently apply theoretical technical principles to product design.
- Must have knowledge of various software packages including Microsoft Office applications.
- Will develop additional knowledge in anatomy and physiology (musculo-skeletal system), fundamentals of orthopedic surgery, mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and materials used in implants and instruments.
