PQA /Sr. Quality Engineer (closed)
Primary Function of Position:
This position is approximately 50% supervising of PQA testing and 50% process improvement, reporting metrics, planning, and working with cross-functional teams. It is a “player-coach” role, and the Supervisor must be technically competent in all aspects of the jobs he/she supervises, and able and willing to contribute each workday. Finally, ability to see avenues for improvement among the activity is essential.
Roles and Responsibilities:
This position has responsibility and authority for:
- Staff, train, and manage the team that performs Instruments Product Quality Assurance testing.
- Plan workload for PQA group and prioritize activities.
- Work with production to ensure that schedule is met, including working OT as needed.
- Perform data analysis to identify reliability trends. Publish operational metrics for group.
- Extract and analyze data from robotic systems using software applications.
- Develop and machine fixtures as needed.
- Accurately record detailed observations of non-conformances in the device history record (DHR).
- Manage supplies and equipment.
- Follow all safety and quality system requirements.
- Provide a layer of judgment and support when complex issues require PQA staff to seek assistance.
- Perform functional evaluation of endoscopic instruments. Be a hands-on supervisor.
- Work with manufacturing and quality groups to resolve quality issues.
- Communicate and troubleshoot product non-conformances.
- Conduct process improvements (kaizen) quarterly with cross-functional teams.
- Perform Field Engineer tasks related to system maintenance.
- Use judgment to escalate quality issues as necessary.
- Update process documents as necessary.
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess or demonstrate:
- Supervisory experience and a proven record of supervising and growing non-exempt employees.
- Excellent communication skills, both written and verbal. Able to communicate eloquently up, down, and sideways.
- Have excellent interpersonal skills, including ability to provide written and verbal instruction in both English and Spanish with ability to work across team organizations and cultures.
- Have a demonstrated interest in medical devices, anatomy, surgery, and the biological sciences.
- Be accurate and detail oriented.
- Be diligent, hard working, self motivated, and focused.
- Be organized and able to multi-task in a fast paced environment and not let responsibilities fall through the cracks.
- Have experience that demonstrates your team spirit, flexibility, and a pattern of growth and advancement.
- Be ready to take the next step in advancing your career to this level.
- Have a BS in Engineering; emphasis in Control Systems a plus.
- Be proficient in Excel, Word, and the Windows operating environment; SAP and Agile experience preferred.
- Have strong work experience with applying concepts of lean manufacturing, ISO9001, and six sigma.
- Must be a hands-on team player with a broad background and able to interact cross-functionally to develop improvement strategies and implement solutions.
- Must have an unfailing commitment to continuous improvement.
- Have ability to learn new software applications and technologies quickly and independently.
- Have excellent manual dexterity and patience to learn surgical skills.
- Be willing to work varying shifts.
- Be able to travel to the United States.
- Be physically able to operate and move the robotic system.
- Have clear vision in both eyes.
Preferred to have some of these:
- Experience testing high tech products or software
- Analytical thinking skills
- Basic programming skills
- Leadership experience