Quality Control Supervisor

Universal Balancing (now part of Burke Porter, an Ascential Technologies Company); San Diego (CA); On-site; USD 70,000 - 91,000; Full time

Job summary

A leading company in medical and life sciences seeks a Supervisor for its Quality Control team in San Diego. This role involves managing daily QC operations, ensuring product compliance with regulatory standards, and mentoring team members. Ideal candidates have a strong background in quality assurance, proven leadership skills, and relevant industry experience.

Benefits

Comprehensive benefits package

Qualifications

• 3-5 years of experience in a Quality Control role within the life science industry.
• 1-2 years of supervisory experience within QC.
• Experience with Lean manufacturing or Six Sigma methodologies.

Responsibilities

• Supervise the daily operations of the Quality Control team.
• Oversee inspections, testing activities, and manage QC documentation.
• Foster a positive team environment and ensure compliance with quality standards.

Skills

Leadership

Analytical skills

Problem-solving

Attention to detail

Written communication

Verbal communication

Education

Bachelor's degree in a scientific, engineering, or technical field

Associate's degree or equivalent technical certification

Tools

Microsoft Office Suite

Quality Management System software

Job description

Ascential Medical & Life Sciences
San Diego, CA 92127, USA

Description

Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Supervisor, Quality Control to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics.

POSITION SUMMARY:

The Quality Control (QC) Supervisor oversees the daily operations of the Quality Control team, ensuring that incoming materials, in-process components, and finished products meet established quality standards, specifications, and regulatory requirements (including FDA QSR, ISO 13485, ISO 9001, and other applicable global regulations). This role involves direct supervision of QC technicians, coordination of inspection activities, data analysis, problem-solving, and driving continuous improvement within the QC function to support the overall Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

Key Responsibilities:

• Lead, train, mentor, and supervise a team of QC inspectors technicians.
• Schedule and assign daily/weekly inspection tasks to ensure efficient workflow and timely product release.
• Conduct performance evaluations, provide feedback, and support the professional development of QC staff.
• Ensure team adherence to safety protocols, company policies, and Good Manufacturing Practices (GMP).
• Foster a positive and collaborative team environment focused on quality and compliance.

Quality Control Operations:

• Oversee incoming, FAI, in-process, and final inspection and testing activities according to established procedures and specifications.
• Ensure proper use, maintenance, and calibration of inspection, measuring, and test equipment (IMTE).
• Oversee all product label issuances and reconciliation.
• Oversee and maintain all serial number issuances and traceability.
• Review and approve inspection records, Device History Records (DHRs), and related QC documentation for accuracy and completeness.
• Manage the identification, segregation, documentation, and disposition of non-conforming materials (NCMRs).
• Coordinate with Manufacturing, Engineering, Supply Chain, and QA departments to resolve quality issues and ensure smooth production flow.

Compliance & Documentation:

• Ensure all QC activities comply with the company's Quality Management System (QMS), FDA 21 CFR Part 820 (QSR), ISO 13485, ISO 9001 and other relevant regulatory requirements.
• Maintain accurate and organized QC records and documentation.
• Assist in the development, review, and revision of QC procedures, work instructions, inspection plans, etc.
• Support internal and external audits (e.g., FDA, Notified Body, customer audits) by providing documentation, explanations, and participating as needed.

Process Improvement & Collaboration:

• Monitor QC metrics (e.g., inspection yields, defect rates, turnaround times) and report on performance trends.
• Implement improvements to inspection methods, equipment, and processes.
• Identify and implement opportunities for continuous improvement within the QC department to enhance efficiency, accuracy, and compliance.
• Participate in or lead root cause investigations for quality issues and contribute to the NCMR and CAPA processes.
• Work closely with Manufacturing to monitor in-process quality and provide timely feedback.
• Support Supplier Quality Management activities, including the evaluation of supplier materials.

Audits & Reporting:

• Prepare the QC department for and participate in internal audits and external regulatory inspections and audits (e.g., FDA, Notified Body, Client).
• Compile, analyze, and report on QC metrics and trends to senior management.

EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED:

Education & Experience:

• Bachelor's degree in a scientific, engineering, or technical field is preferred. Associate's degree or equivalent technical certification with significant relevant experience may be considered.
• Minimum of 3-5 years of experience in a Quality Control role within the life science industry.
• Minimum of 1-2 years of experience in a supervisory or management role within QC.
• Experience with wide range of life science products and technologies (e.g., instruments, disposables, IVDs).
• Experience with Lean manufacturing or Six Sigma methodologies.

Job Complexity:

Manages personnel and monitors operations of a unit or sub-unit. Works on issues of broad scope and complexity, and uses judgement to analyze situations based on data and relevant facts. Requires full knowledge of own area of functional responsibility. Establishes policies and procedures with potential impact to other areas of the organization.

Supervision:

Provides direct supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. A portion of time is normally spent performing individual tasks related to the unit or sub-unit. Generally may supervise semi-skilled and skilled personnel.

Normally receives little instruction on day-to-day work; independently manages the coordination of activities of a section or department with responsibility for resources, methods, and results.

Responsible for a high level of internal and external partnerships and for interacting in a manner which reflects positively on the department and is consistent with the company’s policies and core values.

Knowledge, Skills & Abilities:

• Proven leadership and team management skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.

This is an on-site position in San Diego with an annual salary range of $70,000-$91,000, based on experience and qualifications.

Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.

TECHNICAL KNOWLEDGE:

• In-depth knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 9001 standards. Knowledge of other relevant regulations (e.g., MDSAP, EU MDR) is a plus.
• Strong understanding of QC principles, laboratory techniques, testing methodologies, sampling plans (e.g., ANSI/ASQ Z1.4), and statistical analysis.
• Familiarity with laboratory equipment calibration and maintenance requirements.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
• Experience with Quality Management System (QMS) software and/or Enterprise Resource Planning (ERP) systems is desirable.

EFFORT REQUIRED:

Physical Activities:

On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL:

This position may require limited travel.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.