PURPOSE/SUMMARY
The Principal Quality Engineer supports the development and manufacture of Olympus Veran Technologies (OVT) products during all phases of design, development, production, and distribution.
PRIMARY DUTIES AND RESPONSIBILITIES
The Principal Quality Engineer is responsible for:
• Acting as the Quality Representative on Product Development project teams
• Working cross-functionally to generate and maintain product Risk Management file(s)
• Reviewing QMS and product Design Changes
• Defining Inspection and test methods and systems
• Complaint handling and product investigations of device returns
• Support continuous improvement opportunities
• Preparing and maintaining Quality Metrics
• Maintenance of Quality Management System by ensuring compliance to U.S. and international regulatory requirements for medical devices
• Serves as a mentor for the Quality Engineering team to assist in developing Quality Engineering skills
• Leads complex product projects through completion by collaborating with various functions to ensure that all project requirements are met.
• Support design and development projects
o Represent the Quality team. Provide input and coordinate activities related to:
Risk analysis activities (design and process FMEAs).
Oversight of verification and validation activities.
Acceptance criteria and inspection methods of components and assemblies.
Product labeling and specifications.
o Review Design History File.
o Provide project team with guidance on compliance to Product Development Process.
o Assist in regulatory submissions, as required.
• Support and maintain device production and distribution activities, addressing quality issues and resolution using the current quality techniques and principles.
o Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner.
o Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility.
o Identify areas requiring corrective and preventive action, including those resulting from non-conforming product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation.
o Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively
o Quality representative for Material Review Board (MRB) activities.
• Corrective and Preventive Action
o Participates in the CAPA process as required as an assignee or project team lead.
• Support and participate in inspection and test activities
• Support Quality Management System
• Creates product and process performance metrics and acts upon trends with minimal guidance. Monitors product and process performance metrics and acts upon trends (positive or negative).
• Develops and drives measurable Quality improvement relation to products processes and services.
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Location: St. Louis, MO
Listing Date: June 9, 2021
Position: Principal Quality Engineer
Job Type: Full-Time
Education: BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
Direct Report: Vice President of Quality Assurance & Regulatory Affairs
MINIMUM QUALIFICATIONS
Education*:
• BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
• Evidence of continued learning efforts a plus.
• ASQ CQA and/or CQE a plus
Experience*:
• 12+ years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment or equivalent experience required.
• 7+ years working in an FDA regulated environment optimal (5+ years required).
• Leadership Experience: proven ability to lead and mange cross-functional teams, effectively communicate with all levels of management and drive effective change
Skills and Competencies:
• Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards.
• Experience with risk analysis and reliability engineering techniques.
• Identifying requirements, setting realistic scheduling, and meeting deadlines.
• Ability to identify issues, determine root cause, and implement solutions.
• Ensure compliance to standards, regulations, and Company procedures.
• Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.
• Advanced Microsoft software skills including sophisticated Word, Excel and PowerPoint skills preferred. Access, Visio, database, and statistical analysis software experience optimal.
• Sophisticated written and verbal communication skills, including previous experience in procedure, protocol and report writing required.
• Must be highly and effectively organized as well as a flexible self starter, team-oriented, and excellent at prioritization and multitasking.
• A natural at fostering collaborative relationships across all lines of the Company.
Other Considerations (travel/hours availability, etc.):
• Some travel will be required (less than 5%)
• Some extended workdays may be required
• Other project and duties as assigned.
