Senior Manager, Quality Assurance (Clinton, PA)

Pay Transparency:

The pay range for this role is:

The base pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .

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.

Haemonetics is hiring a Senior Manager Quality Assurance - Site based out of its Center of Excellence in Clinton PA. This person is responsible for effective implementation and maintenance of Quality Systems and compliance programs in accordance with MDD 93/42/EEC ISO 13485 CMDR and applicable QSRs (21 CFR) for a specific plant or business unit. This position leads Quality Systems functions and partners closely with Plant Management and cross-functional stakeholders to ensure compliance with quality and regulatory requirements. The role collaborates with teams responsible for CAPA Complaints Environmental Programs Sterilization Management Review Change Control Design Review and manufacturing support to drive quality performance and continuous improvement.

Primary Responsibilities:

• Contributes to defining short-term and long-term strategic direction for the QA function facility and corporation.

• Leads the implementation maintenance and continuous improvement of the sites Quality Management System ensuring compliance with applicable regulatory and quality standards including but not limited to MDD 93/42/EEC ISO 13485 CMDR and QSRs.

• Serves as the sites subject matter expert for the Haemonetics Quality Management System.

• Promotes awareness and understanding of regulatory and customer requirements throughout the organization.

• Oversees site quality system compliance through internal audits management reviews quality meetings KPI monitoring and trend analysis to identify risks and drive continuous improvement.

• Collaborates with Plant Management to ensure design and engineering changes are effectively implemented through quality planning including appropriate verification and validation activities.

• Partners with Plant Management to proactively identify and resolve quality issues integrating quality requirements into manufacturing processes and operations.

• Initiates and monitors corrective and preventive actions (CAPAs) to ensure timely resolution of quality issues and ongoing compliance with written specifications.

• Represents Haemonetics during 2nd-party (e.g. customer contractor) and 3rd-party (e.g. FDA ISO) quality system audits and inspections.

• Oversees incoming in-process and finished goods inspection activities for designated facilities and product families.

• May be accountable for establishing and managing inspection sampling and testing programs to ensure products meet specifications from raw material through finished goods.

• Develops mentors and leads Quality team members fostering technical expertise accountability and continuous professional development.

Qualifications:

• Bachelors degree in Engineering Life Sciences Quality or a related technical discipline; advanced degree (MS MBA or equivalent) preferred.

• 8 years of progressive Quality Assurance or Quality Systems experience within a regulated industry.

• 5 years of leadership experience managing quality teams.

• Demonstrated experience with FDA regulations ISO 13485 MDSAP and global regulatory requirements.

• Medical device biotechnology pharmaceutical or combination product experience.

• Experience supporting manufacturing operations and quality system compliance.

• Experience leading multiple quality functions including CAPA Complaints Design Assurance Audits Validation and Supplier Quality.

• Experience with MDR and/or IVDR regulations strongly preferred.

• Six Sigma Green Belt Black Belt ASQ certification or equivalent quality certification preferred.

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