Senior Manager, Quality Assurance

Regulatory Jobs; Pennsylvania; Vor Ort; USD 124.000 - 212.000; Vollzeit

Benefits dieser Stelle

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

3–5 weeks paid vacation (hourly)

Paid sick time (up to 64 hours)

Zusammenfassung

Haemonetics is hiring a Senior Manager, Quality Assurance for the Center of Excellence in Clinton, PA. This role leads the Quality Systems and compliance programs across the plant, ensuring adherence to MDR, ISO 13485, CMDR, and QSRs. Collaboration with management drives CAPA, audits, and continuous improvement.

The ideal candidate has 8+ years in QA within regulated industries, 5+ years of leadership, and expertise in regulatory requirements, with a strong manufacturing operations background.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 8+ years of progressive QA or Quality Systems experience within a regulated industry.
• 5+ years of leadership experience managing quality teams.
• Experience with FDA regulations, ISO 13485, MDR/IVDR preferred.
• Medical device, biotech, pharma, or combination product experience.
• Experience supporting manufacturing operations and quality system compliance.
• Experience leading multiple quality functions (CAPA, Audits, Design Assurance, Validation, Supplier Quality).
• Six Sigma Green/Black Belt or ASQ certification preferred.

Aufgaben

• Define short- and long-term QA strategy for the site and corporation.
• Lead implementation and continuous improvement of the Quality Management System.
• Serve as SME for the Haemonetics Quality Management System.
• Promote awareness of regulatory and customer requirements.
• Oversee internal audits, management reviews, KPI monitoring and trend analysis.
• Collaborate with Plant Management on design changes and quality planning.
• Identify and resolve quality issues; integrate requirements into processes.
• Initiate and monitor CAPAs for timely resolution and compliance.
• Represent Haemonetics in 2nd- and 3rd-party audits and inspections.
• Oversee incoming, in-process, and finished goods inspections.
• Develop and mentor Quality team members.

Kenntnisse

Leadership

Regulatory knowledge

Quality Systems

CAPA management

Audits

Manufacturing support

Ausbildung

Bachelor's degree in Engineering, Life Sciences, Quality or related

Advanced degree preferred (MS, MBA)

Tools

ASQ certification

Jobbeschreibung

Pay Transparency:

The pay range for this role is:

$124,300.00-$211,700.00/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

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 820, 210, 211) 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 site's 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 site's 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:

• Bachelor's 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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