Quality Manager Jobs

About The Position

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline
• 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.

Nice To Haves

• Advanced degree (MS, MBA, or equivalent) preferred.
• 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.

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• Flexible time off for salaried employees
• Accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees
• 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
• Health and welfare benefits