Supervisor, Quality

About the role

The Quality Supervisor leads a team of Quality specialists, technicians or inspectors focused on incoming product/component inspection, final QC inspection/testing of products, complaint investigation, NCR investigation, or production floor quality support. The Quality Supervisor develops and manages work assignments, analyzes and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues.

In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other regulatory standards, as applicable.

Responsibilities

• Lead and manage assigned Quality staff to ensure effective Customer complaint and CAPA management.
• Lead and manage assigned Quality staff to effectively execute site calibration and maintenance records; training records; DHR records and environmental control monitoring.
• Lead and manage assigned Quality staff to effectively execute QC inspection procedures and capture associated non conformances.
• Lead and manage assigned Quality staff to effectively investigate non conformances.
• Lead the team in providing effective production floor Quality support.
• Lead and manage assigned Quality staff in effectively managing nonconforming materials including proper disposition and recordkeeping.
• Establish individual and team objectives to attain key metric performance and ensure alignment to overall Quality strategy.
• Analyze and trend Quality data to identify and drive product/service and process improvements.
• Lead the Team’s talent development processes and knowledge development.
• Assume other duties as assigned.

Requirements

• Bachelor’s Degree (Engineering/Scientific)
• Minimum 4 years of production Quality and/or Quality Management Systems experience
• Minimum 4 years of experience in healthcare, medical device or other regulated industry
• Minimum 2 years of experience leading a team and/or supervising employees

Preferred

• ASQ, QSR, or familiarity with QSR/GMP regulations preferred

Skills

• Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency
• Teamwork: Collaborates with others. Works in a professional manner to support team actions
• Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities
• Communication: Constructs clear written communication. Keeps manager and co-workers informed
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word
• Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction
• Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements

Benefits

• Market competitive pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits
• Long/short term disability coverage
• 401(K) with company match
• Maternity and parental leave
• Additional add on benefits/discounts for programs such as pet insurance
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career

Pay

Pay range for this opportunity is $79,687.50 - $103,125.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.