Quality Control Laboratory Manager

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 100,000 - 130,000; Full time

Job summary

An established industry player in medical equipment manufacturing is seeking a Quality Control Manager to lead their Quality Control operations. This role is pivotal in ensuring the implementation of a robust Quality Management System in compliance with ISO 13485 and FDA regulations. The successful candidate will oversee audits, mentor the Quality Control team, and collaborate with cross-functional teams to enhance manufacturing processes. If you have a passion for quality assurance and a proven track record in a regulated environment, this is an exciting opportunity to make a significant impact in a forward-thinking organization.

Qualifications

• 7+ years of experience in quality control within a regulated manufacturing environment.
• In-depth knowledge of ISO 13485 and FDA regulations.

Responsibilities

• Oversee Quality Control operations and ensure compliance with industry standards.
• Drive continuous improvement by analyzing quality metrics and implementing CAPA.

Skills

Quality Control

Leadership

Analytical Skills

Problem-Solving

Communication

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Quality

Bachelor’s degree in a related discipline

Tools

Quality Management Software

Statistical Analysis Tools (Minitab)

Job description

This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $130,000.00/yr

Responsibilities:

• Oversee and manage the site's Quality Control operations, including material sampling, product inspections, calibrations, and testing, ensuring alignment with industry standards and customer expectations.
• Ensure the effective implementation and ongoing compliance of the Quality Management System (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820 regulations.
• Lead and coordinate internal and external audits, ensuring adherence to regulatory requirements, corporate quality policies, and customer specifications.
• Drive continuous improvement by analyzing quality metrics, implementing corrective and preventive actions (CAPA), and refining process controls to enhance efficiency.
• Supervise and mentor the Quality Control team, fostering a culture of operational excellence through training, coaching, and performance management.
• Partner with cross-functional teams, including engineering, production, and regulatory affairs, to address quality concerns and improve manufacturing processes.

Qualifications:

• Bachelor’s degree in Engineering, Quality, or a related discipline.
• A minimum of 7 years of experience in quality control or assurance within a regulated manufacturing environment, ideally in the medical device sector.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and relevant quality system regulations.
• Hands-on experience with process validation, risk management, CAPA implementation, and statistical quality control methodologies.
• Proficiency in metrology, calibration procedures, and inspection techniques.
• Strong leadership abilities with a proven track record of managing teams and driving quality initiatives.
• Excellent analytical, problem-solving, and communication skills.
• Familiarity with quality management software and statistical analysis tools (such as Minitab) is a plus.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Management, Science, and Manufacturing

Industries

Medical Equipment Manufacturing