Quality Control Supervisor

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

Job summary

Envista is seeking a QC Supervisor to lead quality control activities for incoming materials and finished medical devices. You will oversee DHR closure, drive continuous improvement, and ensure inspections meet procedures. On-site work five days a week is required.

The role requires a Bachelor's degree and 5+ years in QA/QC in regulated environments, with strong communication and risk-based decision skills. Fluency in English is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Science, Quality or related discipline.
• Minimum 5 years in Quality Control/QA/Manufacturing Quality within a regulated industry.
• Experience supervising or leading a team.
• Knowledge of ISO 13485 for medical devices and 21 CFR 820.

Responsibilities

• Lead and manage daily activities of QC inspectors and lab technicians.
• Develop and maintain tracking tool for resource allocation and workload management.
• Monitor team performance and KPIs.
• Ensure inspections align with approved procedures.
• Lead containment and support CAPA investigations.
• Support internal and external audits and regulatory inspections.

Skills

Communication

Team leadership

Analytical skills

Risk-based decisions

Cross-functional collaboration

Education

Bachelor's degree

Tools

ISO 13485

21 CFR 820

Job description

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 analyzes 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 #LI-RJ1 IND123

Target Market Salary Range

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. For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan $94,900 - $116,000

Operating Company

Nobel Biocare Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf. Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.