QA QC Specialist - Malvern, PA
2 days ago
Job description
QA/QC Specialist
Location: Hill Laboratories, Frazer, PA
Department: Quality Assurance / Quality Control
Employment Type: Full-Time
Reports To: Quality Management
About the Role
The QA/QC Specialist reports to the Quality Manager and collaborates closely with Manufacturing and Engineering. This role ensures that products, materials, and processes comply with internal quality standards, customer requirements, and regulatory expectations. This role supports both Quality Assurance (QA) and Quality Control (QC) functions with an emphasis on documentation control, investigations (NC/CAPA), audit support, and continuous improvement within a regulated manufacturing environment. The role combines hands-on quality activities with opportunities to strengthen and improve the company's Quality Management System (QMS).
About Us
Since 1945, our company has been a leader in the manufacturing of high-quality medical tables. We pride ourselves on our commitment to excellence, innovation, and a supportive work environment.
Key Responsibilities:
Quality Assurance (Primary Focus)
- Review, approve, and document quality-related records and processes
- Perform root-cause investigations including Corrective and Preventive Actions (CAPA)
- Coordinate management of nonconformances (NCs) with the Quality Team.
- Administer document control processes including SOPs, work instructions, DMR/DHR documentation, and training records
- Participate in and help conduct internal audits; support external audits and track findings to closure
- Coordinate with Quality Management to track, analyze, and report quality metrics to identify trends and drive improvement initiatives.
- Communicate quality deficiencies and compliance issues to management
- Collaborate cross-functionally with Engineering, Assembly, and Production
- Assist with customer complaint investigations and resolutions
- Support change control and engineering change order activities
- Identify opportunities to improve procedures, controls, and quality system effectiveness
Quality Control (QC)
- Review and disposition production nonconforming material
- Support floor-level containment activities
- Verify corrective actions are implemented in production
- Assist with incoming inspection oversight (as needed)
- Interface with Welding QC Specialist for weld-related quality concerns
Qualifications:
Education & Experience
- Bachelor's degree in science, engineering, or related field preferred, or equivalent technical experience
- Working knowledge of ISO 13485 and FDA 21 CFR 820 strongly preferred.
- Experience in quality assurance and quality control functions in a regulated manufacturing environment
- Strong understanding of quality systems, audits, document control, and CAPA process
- Excellent written and verbal communication skills
Skills & Abilities
- Critical thinker with attention to detail and strong organizational skills
- Proficient with Microsoft Office and quality management systems (QMS)
- Ability to work independently and collaboratively
- Adaptable to fast-paced environment with changing work priorities.
- Self-motivated with a strong sense of accountability.
- Demonstrated initiative and problem-solving ability.
Physical & Work Environment Requirements
- Ability to work in a manufacturing/shop floor environment with exposure to noise, dust, oils, grease, and solvents.
- Stand, walk, or kneel for extended periods.
- Occasionally push, pull, or carry light to medium weights (up to 50 pounds).
- Occasional local travel required.
Why Join Us
At Hill Laboratories, we take pride in delivering high-quality products and fostering a culture of continuous improvement. As a member of our team, you will:
- Play a key role in upholding quality and compliance standards.
- Work in a collaborative and safety-focused environment.
- Access opportunities for professional growth.
- Receive competitive pay and benefits including bonus & profit sharing.
Job Type: Full-time
Pay: $62, $75,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
Work Location: In person
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