Quality Assurance Manager

About the Role

The Quality Manager is a hands‑on role that requires aptitude and energy to build a Quality Management System (QMS) from the ground up. The operation does not fall under regulatory guidelines, so a regulatory background is not required. The Quality Manager will champion quality by design and continuous improvement, ensuring every product is processed, tested, packaged, stored, and distributed to the company’s exceptionally high standards. This role partners across internal manufacturing facilities, external contract manufacturers, and suppliers to create an interdependent global manufacturing network that delivers a compliant, on‑time, and reliable supply to customers. The position reports to the Associate Director of Operations, interfaces directly with all functional areas, and interacts daily with senior leadership.

Responsibilities

• Support implementation of all Quality processes.
• Coordinate Quality activities for the assigned manufacturing unit.
• Analyze quality data to make recommendations for improvement focus areas.
• Develop and implement improvements via Kaizens.
• Work closely with Engineering to influence technical design decisions, meet custom product requirements, and reach business objectives.
• Implement containment, corrective actions, and follow‑up on quality issues—including facilitation of responses to findings and handling of Quality case documentation.
• Lead effective problem‑solving activities to investigate nonconformities.
• Serve as Quality liaison with support groups and cross‑functional teams.
• Coordinate Quality training.
• Primary liaison for supplier quality activities.
• Write, review, and approve Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
• Promote company strategic, departmental operational excellence and manufacturing initiatives.
• Act as the quality representative on capital projects.
• Provide engineering and technical support for current products and new product launches.
• Interface with customer quality representatives concerning quality problems and assure effective corrective action implementation.
• Interpret customer specifications and requirements.
• Maintain good internal and external supplier quality levels.
• Design and implement methods for process improvement, testing, and inspection.
• Develop and analyze quality metrics and initiate change as needed.

General Requirements

• Ability to work with all levels of business customers in a highly dynamic environment.
• Comfortable collaborating across various teams, including functional and procurement leadership.
• Willingness and ability to work flexible hours.

Qualifications

• BS Degree in Mechanical or Industrial Engineering preferred, or equivalent work experience may be considered.
• Minimum of five years of quality engineering experience in a manufacturing environment preferred.

Required Experience & Skills

• Effective written and verbal communication skills.
• Strong supervisory and leadership skills; experience leading a team.
• Experience with SAP ERP system.
• Time management: ability to manage changing workload and complete tasks independently.
• Demonstrated analytical problem solving/decision making with a logical approach, even amid obstacles or ambiguity.
• Ability to understand technical specifications and requirements.
• High proficiency in Excel, Word, PowerPoint; familiarity with Power BI and Access a plus.
• Solid understanding of quality tools such as statistical process control, Pareto charts, 8D problem solving, FMEA, GR&R, FAI, CPK, PPAP, etc.
• Ability to lead and facilitate training and continuous improvement initiatives.

Required Skills

• Analytical Problem Solving
• Analytical Thinking
• Capital Projects
• Case Documentation
• cGMP Compliance
• Decision Making
• Detail‑Oriented
• Driving Continuous Improvement
• Enterprise Resource Planning (ERP)
• Key Performance Indicators (KPI)
• Operational Excellence
• Oral Communications
• People Leadership
• Process Improvements
• Quality Auditing
• Quality Control Systems
• Quality Documentation
• Quality Management Standards
• Quality Management Systems (QMS)
• Root Cause Analysis (RCA)
• SAP Business Technology Platform (SAP BTP)
• SAP Enterprise Resource Planning (ERP)
• SAP Project System (PS)
• SAP Systems