Quality Systems Engineer I, Plasma

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

Job summary

Haemonetics seeks a Quality Engineer I to support manufacturing and quality operations in a high-volume setting, ensuring products and processes meet defined quality standards. This role collaborates with Operations and Engineering to maintain compliance with ISO 13485, FDA 21 CFR Part 820, and other regulations.

You will work cross-functionally on CAPA, process improvements and supplier changes, participate in risk analyses, and contribute to quality system initiatives.

Qualifications

• Bachelor's degree in engineering or related field.
• Related experience in a regulated manufacturing environment.
• Excellent organization skills.
• Experience performing root cause analysis and statistical process control.
• Previous experience in medical device, preferred.

Responsibilities

• Work with relevant departments and stakeholders to investigate CAPA, non-conformances, defects, and process failures to identify areas in need of process improvement.
• 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 CAPA, cost reduction, process changes, manufacturing transfers 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 Manufacturing Engineering, Operations, Supplier Quality, Quality Control, and R&D teams as needed providing quality guidance.

Skills

Organization skills

Root cause analysis

Statistical process control

Education

Bachelor's Degree in Engineering or related field

Job description

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].

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

The Quality Engineer I supports manufacturing and quality operations by ensuring products and processes meet defined quality standards. This role works closely with Operations and Engineering teams in a high-volume production environment that utilizes automated equipment, vision inspection systems, and plastic injection molding processes. This individual will help maintain compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations, and work cross-functionally to support production and quality initiatives.

Primary Responsibilities

• 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 CAPA, cost reduction, process changes, manufacturing transfers 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 Manufacturing Engineering, Operations, Supplier Quality, Quality Control, and R&D teams as needed providing quality guidance.

Qualifications

• Bachelor's Degree in Engineering or related field.
• Related experience in a regulated manufacturing environment.
• Excellent organization skills.
• Experience performing root cause analysis and statistical process control.
• Previous experience in medical device, preferred.

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