Quality Systems Engineer

Haemonetics•Clinton, PA

1d•$68,200 - $116,000

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 develops and coordinates quality systems, procedures, test methods, and problem resolutions for existing and new products. It supports manufacturing, product, and customer quality requirements; product improvement and supplier qualification activities; complaint investigations, CAPA, cost reduction, design changes, new products, and quality system excellence. The role also maintains GMP and regulatory records, monitors quality performance, and provides quality guidance to cross-functional teams. The position carries supervisory responsibilities in accordance with organizational policies and applicable laws, including interviewing, hiring, training and developing employees; planning and directing work; evaluating performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

Requirements

Bachelor’s degree in Engineering, Life Science, 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, and problem definitions and resolutions for existing and new products in compliance with the QMS.
Investigate CAPA, non-conformances, defects, and process failures with relevant departments and stakeholders; identify process improvement needs, determine cost of quality, and lead or participate in resolutions.
Support the QC Hold process by assessing product issues, providing required QA input, taking necessary actions, and communicating hold information to relevant stakeholders.
Assist with manufacturing quality systems and product 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 analyses as needed.
Develop, review, and challenge quality-driven test systems and procedures to ensure products meet their 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, 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 for non-sales roles, subject to applicable plan terms
Potential eligibility to participate in the Company’s long-term incentive plan, depending on role