Senior Manager, Quality Operations (Medical Device, Production and Process Control)

Job Description

The Sr. Manager, Quality Operations is a hands-on tactical Quality leader responsible for ensuring overseeing and enhancing the quality of laboratory production and manufacturing operations, with a specific focus on production processes and the control elements of the Quality Management Systems (QMS). 

This role ensures that all production activities comply with industry standards, regulatory requirements, and internal Quality objects, driving continuous improvement and operational excellence.

This is an Onsite position. 

Responsibilities:

Design Control & Development Quality Oversight 

• Supports R&D and cross-functional teams in applying design controls from feasibility through design transfer.
• Ensure design transfer to production includes validation processes, review and approval of methods, and training and documentation.
• Participate and contribute to Design inputs/outputs reviews, verification and validation planning, Design transfer, and Design history to ensure quality and regulatory integration throughout the device development and manufacturing.

Production Process Monitoring and Controls 

• Establish processes and procedures, work instructions, and templates for production and process controls programs per FDA 21 CFR Part 820.70
• Oversee the continuous monitoring of the production processes using methodologies such as Statistical Process Control (SPC) to ensure operation remains within the defined parameters and meet quality standards.
• Implement and manage control tools including control chards, run charts, tracking and analyze production data for trends, deviations, and improvement opportunities.

Inspection, Testing, and Data Management

• Ensure robust data management practices for accurate tracking, analysis, and reporting of production metrics.
• Direct the identification, investigations, documentation and resolution of nonconformances in production, ensuring timely implementation of corrective and preventive actions (CAPA) to address root causes and prevent recurrence.
• Oversee the Quality of incoming materials and components through the supplier audits, quality checks, and strong supplier relationships ensuring that all inputs meet required standards.
• Provide quality assurance guidance for developing production including receiving and inspection reviews, material non-conformance investigations, standard operating procedures and work instructions.
• In collaboration with procurement and supplier Quality function, provide input to SCAR investigations and supplier performance management. 

Equipment Calibration and Maintenance

• Ensure all production equipment is properly calibrated and maintained according to established procedures, master schedule, and supporting process control and product quality.
• Review and approve equipment IQOQPQ protocols and reports, calibrations, and maintenance records.
• Take ownership of implementation and maintenance of change control program requirements for production and process controls activities.
• Collaborate with cross-functional partners to initiate and close out change controls related to processes, equipment, production software, test methods, and post-market activities. 
• Lead equipment investigations and documentation of Non-conformances, Deviations, Out-of-specifications results, and CAPA effectiveness reviews.
• Manage production related document change requests, work instructions updates, and training records reviews. 

Document Control and Compliance 

• Maintain accurate and up-to-date documentation of production processes, Quality standards, inspection results, and processes changes to ensure traceability and compliance with industry and regulatory standards.

Continuous Improvement and Process Optimization

•  Drive continuous improvement initiatives using Lean, Six Sigma methodologies to reduce waste, minimize defects, and enhance process efficiency.
• Lead root cause analysis and process improvement projects to optimize production workflows and outcomes.
• Collaborate with cross-functional teams to integrate quality in all aspects of the product lifecycle and resolve quality-related issues

Qualifications:

Required Work Experience: 

• 5+ years of experience in a quality leadership role within a regulated manufacturing environment for Medical Devices and or/In Vitro Diagnostics industry
• Hands-on experience with authoring, review, and implementation of Quality production and process controls policies and procedures
• Proven ability to analyze data, conduct root-cause analysis, and implement effective CAPA processes.
• Demonstrated Experience applying Medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA). 

Preferred Work Experience: 

• Technical writing 

Physical and Mental Requirements: 

• Strong attention to detail for thorough documentation to ensure consistency in documentation. 
• Excellent problem-solving skills to identify and address quality issues effectively. 
• Ability to manage multiple work projects to meet deadlines while maintaining accuracy. 
• Must be able to occasionally move and lift objects of up to 25 pounds

Knowledge: 

• Broad-based technical knowledge and skills in diverse areas of business such as quality engineering, quality assurance, quality systems, regulatory affairs, laboratory operations, GCP, and GMP operations. 
• Demonstrated knowledge of design controls, risk management, and regulatory compliance framework.
• Strong working knowledge of applicable regulations, such as but not limited to, the medical device regulations: FDA 21 CFR Part 820 Quality Systems Regulations/new Quality Management System Regulation and ISO 13485 standards. Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements.
• Medical device related certification or CSV/GAMP 5 training 

Skills: 

• In-depth knowledge of QMS standards and regulatory requirements relevant to manufacturing 
• Experience in supplier quality management, equipment IQOQPQ, calibration, and document control
• Strong expertise in process control methodologies
• Excellent cross-functional collaboration skills
• Strong communication skills for effective interaction with internal teams’ suppliers, and regulatory bodies

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Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.