Quality Systems Engineer

Haemonetics Interventional Technologies; Pennsylvania; On-site; USD 68,000 - 116,000; Full time

Benefits offered by this job

401(k) with match

Employee stock purchase plan

Flexible time off

Paid vacation

Paid sick time

Holidays

Parental leave

Disability insurance

Tuition reimbursement

Health benefits

Job 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.

Responsibilities include developing and coordinating quality systems and procedures, investigating CAPA and non-conformances, supporting QC holds, and ensuring qualifications

Qualifications

• 3–5+ years of work experience in a related function is required.
• Professional experience with Statistical Process Control.
• Computer knowledge and experience with Microsoft Office and document management systems (e.g., Agile).

Responsibilities

• Develop and coordinate implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products in compliance with QMS.
• Investigate CAPA, non-conformances, defects, and process failures to identify areas for improvement and drive resolution.
• Support QC Hold process by providing QA input and communicating hold information to stakeholders.
• Assist in manufacturing quality systems and customer quality requirements.
• Support product improvement projects (IQ/OQ/PQ) and supplier changes to ensure qualifications are met.
• Lead or participate in teams related to complaint investigations, CAPA, cost reduction, design changes, and quality system excellence.
• Conduct risk analyses as needed.
• Develop, review and challenge existing quality-driven test systems and procedures.
• Maintain records to ensure GMP/regulatory compliance.
• Monitor internal and external quality levels to trigger improvements.

Skills

Statistical Process Control

Quality improvement

Problem solving

Documentation

Education

Bachelor's Degree in Engineering or Life Science

Tools

Microsoft Office

Agile

Document management systems

Job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

Job 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.

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).

Pay Transparency

The pay range for this role is: $68,200.00-$116,000.00/Annual The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.

Benefits

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation,

• a 401(k) with up to a 6% employer match and no vesting period
• an 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

Contact Information

If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email [e-mail].

EEO Policy Statement

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.