Quality Systems Engineer

About the role

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.

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).

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• Flexible time off for salaried employees
• For hourly employees: accrual of three to five weeks’ vacation annually (based on tenure)
• Accrual of up to 64 hours (annually) of paid sick time
• Paid and/or floating holidays
• Parental leave
• Short- and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits

Pay

The pay range for this role is: $68,200.00‑$116,000.00 per annual. The base pay actually offered to the successful candidate will take into account, without