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.

Skill/Job Requirements:

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