BioTalent
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Base pay range $130,000.00/yr - $160,000.00/yr
Direct message the job poster from BioTalent
RA/QA Medtech & Life Sciences Recruitment for New England Role Overview The Operations Quality Manager leads quality execution across multiple manufacturing, assembly, distribution, and laboratory environments, including support for new product introductions and global product transfers. This role is responsible for driving consistent quality performance, strengthening processes, and ensuring products meet internal and external requirements throughout their lifecycle.
The position oversees quality planning and project execution across several operational functions, using data-driven analysis to identify trends, address risks, and improve both product and process outcomes. This leader plays a critical role in advancing continuous improvement efforts and supporting high levels of customer satisfaction.
Key Responsibilities
Lead and allocate quality resources across manufacturing, assembly, kitting, distribution, laboratory, and calibration functions
Oversee quality activities related to new product introductions and global manufacturing transfers
Drive investigation and resolution of product quality issues, deviations, and nonconformances
Establish, monitor, and report key quality performance metrics
Lead corrective and preventive action initiatives and continuous improvement projects
Set annual objectives, performance expectations, and development plans for team members
Partner cross-functionally with engineering, R&D, supply chain, and external manufacturing partners to resolve quality issues
Promote and implement best practices to improve process robustness and operational effectiveness
Qualifications
Bachelor’s degree in Engineering or a scientific discipline; advanced degree preferred
5+ years of experience in quality operations or a related technical field
2+ years of experience leading or managing teams
Strong working knowledge of corrective and preventive action systems and internal auditing
Experience with regulated quality management systems (e.g., ISO-based standards)
Familiarity with risk management, process capability, product qualification, and new product development
Proven ability to lead change and implement continuous improvement methodologies
Strong leadership, communication, and stakeholder engagement skills
Ability to operate independently across multiple teams and functional areas
Solid technical writing and documentation review capabilities
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
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Base pay range $130,000.00/yr - $160,000.00/yr
Direct message the job poster from BioTalent
RA/QA Medtech & Life Sciences Recruitment for New England Role Overview The Operations Quality Manager leads quality execution across multiple manufacturing, assembly, distribution, and laboratory environments, including support for new product introductions and global product transfers. This role is responsible for driving consistent quality performance, strengthening processes, and ensuring products meet internal and external requirements throughout their lifecycle.
The position oversees quality planning and project execution across several operational functions, using data-driven analysis to identify trends, address risks, and improve both product and process outcomes. This leader plays a critical role in advancing continuous improvement efforts and supporting high levels of customer satisfaction.
Key Responsibilities
Lead and allocate quality resources across manufacturing, assembly, kitting, distribution, laboratory, and calibration functions
Oversee quality activities related to new product introductions and global manufacturing transfers
Drive investigation and resolution of product quality issues, deviations, and nonconformances
Establish, monitor, and report key quality performance metrics
Lead corrective and preventive action initiatives and continuous improvement projects
Set annual objectives, performance expectations, and development plans for team members
Partner cross-functionally with engineering, R&D, supply chain, and external manufacturing partners to resolve quality issues
Promote and implement best practices to improve process robustness and operational effectiveness
Qualifications
Bachelor’s degree in Engineering or a scientific discipline; advanced degree preferred
5+ years of experience in quality operations or a related technical field
2+ years of experience leading or managing teams
Strong working knowledge of corrective and preventive action systems and internal auditing
Experience with regulated quality management systems (e.g., ISO-based standards)
Familiarity with risk management, process capability, product qualification, and new product development
Proven ability to lead change and implement continuous improvement methodologies
Strong leadership, communication, and stakeholder engagement skills
Ability to operate independently across multiple teams and functional areas
Solid technical writing and documentation review capabilities
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
#J-18808-Ljbffr