Quality Systems Engineer

Regulatory Toolkit; Pennsylvania; Sur place; USD 68 000 - 116 000; Plein temps

Avantages offerts par ce poste

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

Vacation and holidays

Paid sick time

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Résumé du poste

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.

You will develop and implement quality systems, investigate CAPA and non-conformances, support QC hold processes, and collaborate with R&D, Manufacturing, Supply Chain, and

Qualifications

• Bachelor's degree in engineering or life sciences.
• 3–5+ years of relevant work experience.
• Experience with Statistical Process Control.
• Proficiency with Microsoft Office and document management systems (e.g., Agile).

Responsabilités

• Develop and implement quality systems, procedures, and test methods per QMS.
• Investigate CAPA, non-conformances and defects; lead resolutions.
• Support QC hold process and communicate findings to stakeholders.
• Assist in manufacturing quality systems and supplier changes.
• Lead or participate in projects related to complaint investigation and quality system excellence.
• Conduct risk analysis and support quality improvement initiatives.
• Collaborate with multiple departments to provide quality guidance.
• Maintain GMP/regulatory records and monitor product quality.

Connaissances

Statistical Process Control

Microsoft Office

Agile

Formation

Bachelor's degree in Engineering or Life Science

Outils

Agile

Description du poste

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).

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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