Quality Control Supervisor

Nobel Biocare; Yorba Linda (CA); On-site; USD 95,000 - 116,000; Full time

Job summary

Nobel Biocare in Yorba Linda, CA, seeks a QC Supervisor to lead quality control activities for incoming materials and finished medical devices, review and close DHRs for product release, and drive continuous improvement through data and risk-based decisions.

The role requires a Bachelor’s in engineering or life science, 5+ years in a regulated quality environment, on-site work five days a week, strong documentation, and fluency in English; it also covers supervising inspectors, monitoring KPIs,

Qualifications

• Bachelor's degree in Engineering, Life Science, Quality or related discipline preferred.
• Minimum 5 years in Quality Control/QA or Manufacturing Quality within a regulated industry.
• Experience supervising or leading a team.
• Knowledge of ISO 13485 and 21 CFR 820.
• Effective written and verbal communication across functions.
• Strong analytical and documentation capabilities.
• Ability to make risk-based quality decisions under pressure.
• Fluent English.

Responsibilities

• Lead and manage daily activities of QC inspectors and lab technicians.
• Develop and maintain tracking to allocate resources, manage workload, and report team activity.
• Monitor team performance and KPIs.
• Ensure inspections on incoming materials and final products follow procedures.
• Perform inspections as needed.
• Monitor and analyze nonconformances.
• Drive continuous improvement using data, metrics and risk-based decisions.
• Lead containment, root-cause investigations and CAPA implementation.
• Ensure inspection plans and test procedures are effective.
• Support internal and external audits and regulatory inspections.
• Foster a culture of quality and accountability.

Skills

Team Leadership

Resource Tracking

Quality Metrics

Inspection Procedures

CAPA

Audits

Regulatory Knowledge

Documentation

Problem Solving

English Proficiency

Education

Bachelor's degree in Engineering, Life Science, Quality

Job description

The QC Supervisor leads and oversees Quality Control activities to ensure that incoming materials and finished medical devices conform to specifications. The QC Supervisor leads and oversees the review and closure of Device History Records (DHR) for final product release. The QC Supervisor monitors and analyses non-conformances and drives continuous improvement.

Must be willing to work on-site 5 days per week.

• Lead and and manage daily activities of QC inspectors and lab technicians
• Develop and maintain a tracking tool to ensure effective resource allocation, workload management, and reporting of the team activity
• Monitor team performance and KPIs
• Ensure incoming and final product inspections are performed according to approved procedures
• Perform inspection activities at need
• Monitor and analyses nonconformances
• Drive continuous improvement initiatives using inspection data, quality metrics, and risk-based decision making
• Lead containment activities and support root cause investigations and CAPA implementation
• Ensure inspection plans and test procedures are effective
• Support internal and external audits and Regulatory inspections

Foster a culture of quality and accountability.

Job Requirements

• Bachelors degree in Engineering, Life Science, Quality or a related discipline preferred
• Minimum 5 years of experience in Quality Control, Quality Assurance, or Manufacturing Quality within a regulated industry
• Previous experience supervising or leading a team
• Knowledge of standards and regulation including: ISO 13485 for medical device and 21 CFR 820
• Communicates effectively (verbal and written) across functions
• Strong analytical and documentation capabilities
• Objective problem-solving skills with the ability to make firm, risk-based quality decisions under pressure
• Fluent English

IND123

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$94,900 - $116,000

Operating company:Nobel Biocare

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