Quality Manager

Position Summary

The Quality Manager is responsible for the planning, coordination, and implementation of Quality Management System (QMS) processes to ensure quality in production and shipping of products, to meet ISO and regulatory requirements and standards, and to support business requirements.

Essential Duties and Responsibilities

• Accountable for effective integration and execution of company and customer, quality assurance and quality control (QA/QC) requirements in new product development, process validation/verification, production, storage and distribution of product in collaboration from the entire company’s Quality Organization.
• Approves product quality plans, in collaboration with the customer, when applicable.
• Leads production risk analysis and mitigation program, including but not limited to PFMEA.
• Coordinate quality department resource assignment to optimize and assure product quality throughout the project timelines and lifecycle.
• Ensures that team members are meeting goals and timelines, as well as, working with Production team in meeting quality goals.
• Conducts management and employee meetings regarding quality related issues, production issues and procedures related to quality that directly relate to requirements.
• Ensures staff and employees have a clear understanding of customer quality requirements.
• Reviews technical problems and procedures of all departments and recommends solutions to problems or changes in local or global procedures.
• Accountable for customer interface with quality aspects of product qualification, quality planning and specification compliance related matters. Allocates Quality Staff as appropriate.
• Collaborates with all department managers and senior staff to ensure the quality processes are running efficiently and effectively.
• Responsible for the Quality Management System (QMS) maintenance and development. Lead, support and delegate quality system improvement programs and initiatives in collaboration with the entire company’s Quality Organization. Maintain QMS certifications. Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Quality Management System Management Representative. Manage internal and external quality system audits and communicate results to team. Lead and coordinate observation corrective action.
• Primary interface with regulatory auditors.
• Maintain trend analysis on key quality system effectiveness metrics. Inform plant leadership team of trends, propose and coordinate action to prevent adverse trends development and improve performance.
• Schedule and conduct site Management Review Meetings.
• Owner of corrective and preventive action (CAPA) system. Track CAPAs for timeliness of completion, implementation and effectiveness.
• Work with plant and company’s leadership team to establish operational objectives and goals. Monitor progress to ensure goals are achieved.
• Owner of complaint management system. Track, assure resolution, and respond to customer complaints or customer satisfaction issues.
• Owner of ERP quality modules, responsible for content and content maintenance.
• Owner of Document Control/Management System, including: specifications, engineering changes, quality records, QMS documents, etc.
• Owner of equipment calibration and maintenance.
• Accountable for procedural compliance with facility and manufacturing pest controls, environmental controls and microbiological analysis and control.
• Lead and manage quality management system team project meetings, delegate tasks, prioritize activities and manage resources.
• Lead and manage direct reports while fostering personnel development.
• Adheres to the Quality Policy and Core Values of the company.
• Other duties as assigned by Plant Manager and/or Director of Quality.

This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent. The incumbent may be asked to perform other duties as required. The job description may be changed if needed as determined by the Company.

Join Our Team – Where Your Work Matters and Your Well‑Being Comes First

At Atalys, we believe that great work starts with great people — and great people deserve to be supported, valued, and rewarded. When you join our team, you’re not just starting a job; you’re building a career in an environment that celebrates your contributions and invests in your future.

We’re proud to offer a comprehensive benefits package designed to help you thrive both inside and outside of work:

✅ Generous PTO + 11 Paid Holidays

✅ 401(k) with company match

✅ Bonuses & Shift Differentials

✅ Paid Jury Duty, Bereavement Leave

✅ Medical, Dental, Vision

✅ Short-Term & Long-Term disability

✅ Group Term Life Insurance, and Supplement life for employee, spouse and children

✅ Critical Illness, Accident Coverage and Hospital Indemnity

✅ Employee Assistance Program

✅ Quarterly Perfect Attendance Awards

✅ Service Awards Program

Plus — a referral bonus program so you can bring your friends along for the ride!

💼 Apply now and let’s build something amazing together.