Quality Systems Engineer

Haemonetics•Clinton, PA

About The Position

Haemonetics is seeking a Quality Systems Engineer to support its Center of Excellence in Clinton, Pennsylvania. The 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. The position may also carry supervisory responsibilities, including hiring, training, directing, and evaluating employees and resolving workplace issues.

Requirements

Bachelor's degree in Engineering, a Life Science discipline, or a related technical field.
3–5+ years of work experience in a related function.
Professional experience with Statistical Process Control.
Computer knowledge and experience with Microsoft Office and document management systems such as Agile.

Responsibilities

Develop and coordinate implementation of quality systems, procedures, test methods, problem definitions, and resolutions for existing and new products in compliance with the QMS.
Work with relevant departments and stakeholders to investigate CAPA, non-conformances, defects, and process failures; identify process improvements; determine cost of quality; and lead or participate in resolutions.
Support the QC Hold process by understanding product issues, providing required QA input, taking necessary actions, and communicating hold information to relevant stakeholders.
Assist with manufacturing quality systems, product quality, and customer quality requirements.
Support product improvement projects, including validation IQ, OQ, and PQ activities, and supplier changes to ensure qualification requirements are met.
Complete or lead teams and projects related to complaint investigations, CAPA, cost reduction, design changes, new products, and quality system excellence.
Conduct risk analysis as needed.
Develop, review, and challenge quality-driven test systems and procedures to assure products meet intended use.
Maintain records to ensure compliance with GMP and regulatory requirements.
Monitor internal and external quality levels and drive improvements to maintain product compliance.
Contribute to problem-solving efforts on selected projects to improve quality.
Partner with Customer Service, Supply Chain, Sales, Marketing, Legal, Manufacturing, and R&D teams, providing quality guidance as needed.
Carry out supervisory responsibilities in accordance with organizational policies and applicable laws, including interviewing, hiring, training and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

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 of vacation annually based on tenure.
Accrual of up to 64 hours of paid sick time annually.
Paid and/or floating holidays.
Parental leave.
Short- and long-term disability insurance.
Tuition reimbursement.
Health and welfare benefits.
Discretionary annual bonus eligibility for non-sales roles.
Potential eligibility to participate in the company’s long-term incentive plan.