Quality Systems Engineer
Haemonetics
Summary
Haemonetics is seeking a Quality Systems Engineer to support its Center of Excellence in Clinton, PA. This role drives product and process quality improvements through investigations, CAPA ownership, risk analysis, and cross-functional problem-solving to ensure compliance with regulatory and quality system requirements.
Job description
Responsibilities
- Responsible for developing and coordinating implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products, in compliance with QMS.
- Work with relevant departments and stakeholders to investigate CAPA, non-conformances, defects, and process failures in general to identify areas in need of process improvement, to determine the cost of quality and to lead or participate in resolution.
- Support QC Hold process to understand product issues, providing required QA input, taking necessary actions, and communicating hold information to relevant stakeholder groups.
- Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met.
- Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, design changed, new products and quality system excellence.
- Conducts risk analysis as needed.
- Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use.
- Maintains records to ensure compliance to GMP/Regulatory requirements.
- Monitors internal and external quality levels to trigger and drive improvements to maintain product compliance.
- Provide individual contribution in problem solving efforts on selected projects to improve quality.
- Partner with Customer Service, Supply Chain, Sales, Marketing, Legal, Manufacturing and R&D teams as needed providing quality guidance.
- Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications
- Bachelor's Degree - Engineering or Life Science discipline or related technical field
- 3-5+ years of work experience in a related function, required.
- Professional experience with Statistical Process Control.
- Computer knowledge and experience with Microsoft Office and document management systems (for example, Agile).
Requirements
- Bachelor's Degree - Engineering or Life Science discipline or related technical field
- 3-5+ years of work experience in a related function, required.
- Professional experience with Statistical Process Control.
- Computer knowledge and experience with Microsoft Office and document management systems (for example, Agile).
Benefits
- 401(k) Matching
- Employee Stock Purchase Plan
- Flexible Time Off
- Paid Sick Time
- Paid Holidays
- Parental Leave
- Short-term Disability Insurance
- Long-term Disability Insurance
- Tuition Reimbursement
- Health and Welfare Benefits
Company overview
Haemonetics Corporation is a global leader in blood and plasma management solutions, founded in 1971 and headquartered in Boston, Massachusetts. As a publicly traded company listed on the NYSE under the symbol HAE, Haemonetics specializes in developing and manufacturing medical devices and systems for blood component collection, processing, and transfusion management. The company operates across three primary segments: plasma collection, blood center operations, and hospital transfusion services. Haemonetics' innovative product portfolio includes automated blood collection systems, surgical blood salvage devices, hemostasis management systems, and temperature regulation equipment for medical applications. With approximately 3,300 employees worldwide and operations in 16 countries, the company generates annual revenues exceeding $1.3 billion. Haemonetics has established itself as a critical partner to healthcare providers by offering comprehensive solutions that enhance patient safety, improve clinical outcomes, and optimize blood management workflows across the continuum of care.