Quality Manager

Quality Manager Brooksource - 3.7 St. Louis, MO Job Details Contract $105,000 - $135,000 a year 6 hours ago Benefits Health savings account Paid holidays Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Qualifications Computer operation Microsoft Excel Management New product development ISO standards Quality management

ISO 9001 ASQC

Certification Bachelor's degree Quality compliance management Regulatory affairs Quality engineering Productivity software Quality systems Quality assurance within manufacturing Supplier quality assurance (SQA) Full Job Description Quality Manager 100% Onsite (St Louis, MO) 6 month CTH Position Summary Brooksource is currently seeking a Quality Manager for a regulated healthcare manufacturing organization in St. Louis, MO to lead quality improvement efforts for the STL manufacturing facility. The Quality Manager is responsible for implementing and sustaining best‑in‑class quality practices across product and service lines, while ensuring ongoing compliance with domestic and international quality and regulatory standards. This position owns the site Quality Management System (QMS), including its organization, documentation, and maintenance, and ensures compliance with

ISO 9001, ISO 13485, MDSAP, CFR

Part 820/211, EU MDR, and other applicable standards. The Quality Manager serves as the site Management Representative and provides leadership across product/service quality, supplier quality, process quality, new product development quality, and regulatory compliance. What You'll do as a Quality Manager Lead the site's Quality staff to ensure compliance with the QMS and drive continuous improvement. Ensure alignment to manufacturing and servicing operations by supporting Lean efforts and driving quality improvement for products and services. Coach, mentor, and provide day‑to‑day leadership to Quality staff. Work closely with site senior leadership to define & execute organization's quality strategies + tactics. Provide quality perspective and input on future product and service development. Serve as the site Management Representative and lead Management Review activities. Ensure ongoing compliance with applicable domestic + international regulatory and quality standards. Drive continuous improvement through data analysis, improvement initiatives, and process capability enhancements tied to quality KPIs. Lead implementation and maintenance of effective production and process controls. Oversee complaint handling processes to ensure timely customer response and product/process improvements. Ensure adherence to the New Product Development (NPD) process, including definition and tracking of key quality performance metrics. Assess new designs for manufacturability, testability, and reliability to mitigate quality risk and ensure design intent is met. Evaluate supplier qualification risks based on component criticality and supplier process capability. Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR, with appropriate authority and independence per Article 15. Perform other duties as assigned.

Experience, Skills and Abilities Needed Required :

Bachelor's degree in Engineering or related technical field. 8+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience. 8+ years of experience working in an ISO certified environment required. 2+ years in a Quality leadership role. Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC) The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management, and regulatory compliance.

Preferred :

8+ years of experience with medical device or other regulated industries, preferred.

ASQ, QSR

Certification or familiarity with QSR/GMP regulations, preferred. Experience with statistical analysis software and Visio, preferred.

Other :

Excellent problem-solving skills Focus on identification of potential issues and continuous improvement. Experience working on cross-functional teams and on own initiative. Demonstrated excellent organizational, oral and written communications skills. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.

Disclaimer:

Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

EEO:

We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Benefits & Perks:

Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Pay:

$105,000.00 - $135,000.00 per year

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

In person