Quality Systems Engineer
Job in
Northern, Floyd County, Kentucky, USA
Listed on 2026-10-15
Listing for:
Haemonetics Interventional Technologies
Full Time
position Listed on 2026-10-15
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
## Quality Systems Engineer Apply:
Clinton, PA:
Full time:
Posted Today:
R10292
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:
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* 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.
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* Qualifications:
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* * 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). #LI-AR1
** Pay Transparency:
** The pay range for this role is: $68,200.00-$/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…
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