Quality Systems Engineer

haemonetics; Pennsylvania; On-site; USD 68,000 - 116,000; Full time

Benefits offered by this job

401(k) with up to 6% employer match

Health and welfare benefits

Flexible time off

Job summary

Haemonetics is seeking a Quality Systems Engineer to support its Center of Excellence in Clinton, PA. The role drives quality improvements through investigations, CAPA ownership, risk analysis, and cross-functional problem-solving to ensure regulatory compliance.

Responsibilities include developing quality systems, coordinating CAPA investigations, supporting QC Holds, and driving improvements with cross-functional teams. Experience with GMP and document management is required.

Qualifications

• Bachelor's Degree in Engineering or Life Science.
• 3-5+ years of related work experience required.
• Experience with Statistical Process Control.
• Experience with Microsoft Office and document management systems.

Responsibilities

• Develop and coordinate quality systems and procedures in compliance with QMS.
• Investigate CAPA, non-conformances, defects, and process failures for improvements.
• Support QC Hold processes, provide QA input, and communicate hold information.
• Assist in manufacturing quality systems and supplier changes to meet qualifications.
• Lead or participate in projects related to complaints, CAPA, and quality system excellence.
• Conduct risk analyses as needed and review quality-driven test procedures.
• Maintain GMP/regulatory records and monitor quality levels for improvements.
• Collaborate with Customer Service, Supply Chain, Sales, Marketing, Legal, Manufacturing and R&D.

Skills

Statistical Process Control

Microsoft Office

Agile

Education

Bachelor's Degree in Engineering or Life Science

Tools

Microsoft Office

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 Details:

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).

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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.

Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.

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 and, 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, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. 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].

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