Pay is commensurate of experience.
Quality Assurance Manager
Reports To: Vice President / General Manager
Position Summary
The Quality Manager is responsible for leading the Quality Management System (QMS) to ensure the consistent production of products that meet customer, regulatory, and company quality standards. This position oversees quality assurance, quality control, document control, supplier quality, internal and external audits, continuous improvement initiatives, and compliance with ISO 9001 and applicable regulatory requirements. The Quality Manager supervises quality personnel and works cross-functionally with Production, Engineering, Sales, Purchasing, and Operations to improve product quality, manufacturing efficiency, and customer satisfaction.
Essential Responsibilities
Quality Management System (QMS)
- Manage and maintain the ISO 9001 Quality Management System and ensure ongoing compliance with company policies and procedures.
- Administer the document control system, ensuring all controlled documents are accurate, current, approved, and properly distributed.
- Monitor document revisions, engineering change orders, and QMS change orders.
- Maintain document security, confidentiality, and record retention requirements.
- Collaborate with production and engineering teams to update procedures, work instructions, drawings, and customer specifications.
- Print, distribute, and archive-controlled documents as required.
Quality Assurance & Quality Control
- Oversee incoming, in-process, final inspection, and line clearance activities to ensure compliance with specifications.
- Ensure purchased materials and supplier products meet established quality requirements.
- Monitor supplier performance and incoming material quality.
- Supervise quality inspectors, providing training, guidance, coaching, and performance feedback.
- Support operator training for inspection, testing, and GMP requirements.
- Utilize statistical process control (SPC), testing equipment, and quality data to monitor process capability and product performance.
- Analyze quality metrics and identify trends, deviations, and opportunities for improvement.
Audits & Regulatory Compliance
- Plan, conduct, and manage Internal Audits.
- Coordinate Customer, ISO, FDA, and other external audits with registrars and regulatory agencies.
- Ensure compliance with ISO 9001, customer requirements, applicable regulatory standards, and company procedures.
- Support Good Manufacturing Practices (GMP) and quality compliance initiatives.
Corrective & Preventive Actions
- Investigate customer complaints and nonconforming products.
- Manage Non-Conformance Reports (NCRs), Return Material Authorizations (RMAs), and Corrective and Preventive Actions (CAPAs) through completion.
- Lead Material Review Board (MRB) meetings and manage material quarantine and disposition activities.
- Identify root causes and implement effective corrective actions to prevent recurrence.
Continuous Improvement
- Lead continuous improvement initiatives to improve quality, productivity, and manufacturing efficiency.
- Participate in new product introduction, validation, and qualification activities.
- Support engineering and sales by providing quality input during quotation and new business development.
- Participate in daily production meetings and monthly business reviews.
- Prepare quality reports and present performance metrics to management.
Safety & Environmental
- Promote compliance with health, safety, and environmental requirements.
- Coordinate environmental and safety initiatives with external consultants and internal leadership.
Qualifications
Education
- Bachelor’s degree in engineering or a related technical field preferred.
Experience
- Minimum of 5 years of Quality Assurance or Quality Management experience in a manufacturing environment.
- Demonstrated experience maintaining and improving an ISO 9001 certified Quality Management System.
- Experience leading internal and external audits.
- Experience with supplier quality, customer quality, document control, CAPA, and continuous improvement initiatives.
- Internal Auditor certification (ISO 9001 or equivalent) is preferred.
Knowledge, Skills & Abilities
- Thorough understanding of ISO 9001 quality management systems and quality assurance principles.
- Knowledge of inspection techniques, testing equipment, SPC, root cause analysis, and quality improvement methodologies.
- Strong leadership, organizational, analytical, and problem-solving skills.
- Excellent verbal and written communication skills.
- High attention to detail with the ability to manage multiple priorities.
- Proficiency with Microsoft Office applications, particularly Excel and Word.
- Experience with IQMS is a plus.
- Ability to work collaboratively across departments while driving accountability and continuous improvement.
Physical Requirements
- Ability to work in both office and manufacturing environments.
- Ability to stand, walk, and occasionally lift up to 25 pounds.
- Ability to inspect manufacturing operations and production processes as needed.
Job Type: Full-time
Pay: From $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience:
- Quality assurance: 5 years (Preferred)
- ISO 9001: 1 year (Preferred)
Location:
- Latrobe, PA 15650 (Required)
Work Location: In person
