Senior QA Leader: Quality Systems & Compliance

Haemonetics Software Solutions; Pennsylvania; On-site; USD 124,300 - 211,700; Full time

Benefits offered by this job

401(k) with employer match

Employee stock purchase plan

Flexible time off

Paid holidays

Tuition reimbursement

Health and welfare benefits

Job summary

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

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 8+ years of progressive Quality Assurance or Quality Systems experience in a regulated industry.
• 5+ years of leadership experience managing quality teams.
• 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.

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.

Skills

Leadership

Regulatory knowledge

Quality systems

CAPA management

Education

Bachelor's degree in Engineering/Life Sciences/Quality

MS / MBA preferred

Job description

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