Manager, Quality Control

Pay Range:

Position Summary:

The position requires management of the day-to-day operations within the various Quality Control groups (including QC laboratory, Incoming QC). Procedures and processes developed and supported must adhere to FDA cGMP and ISO 13485 Medical Device Requirements. Principal testing types include: blood gas and electrolytes, glucose, co-oximetry, general chemistries, and coagulation.

Responsibilities:

• Manage and lead the team, including but not limited to ensuring adequate staffing levels, recruitment, training, development, appraisal, attendance, disciplinary issues, and quick, effective problem resolution that maximizes efficient productivity and delivers a high level of employee engagement.
  • Oversee daily functions of each department and identify opportunities for improvement
• Drive training and development of team members and work closely with department Supervisors to ensure the completion of team and individual goals.
  • Help supervisors organize and schedule workflow in each functional area (Incoming QC and QC lab) to ensure smooth operation.
  • Provide direction and support to all QC-related functions.
• Align with senior leadership initiatives and support corporate goals for the business.
  • Maintain a regular 5on-floor6 presence, regularly adopting GEMBA techniques.
  • Positively engage with personnel to understand challenges and issues through continuous assessment and implement change where necessary.
  • Lead/participate in continuous improvement initiatives in line with the vision of the department and the business.
  • Mentor, motivate, and empower personnel within the team to implement change successfully.
  • Support senior leadership initiatives and specific site goals.
• Partner with Manufacturing, Quality Assurance, Supply Chain, and R&D to resolve product quality issues and support business objectives.
• Establish and monitor quality control systems.
  • Oversee program for the monitoring of temperature-controlled storage areas
  • Identify critical points in the manufacturing processes where quality checks can be added.
  • Develop inventory systems for critical lab supplies, reagents, and reference materials.
• Participate in New Product Development supporting test methods for new product types.
  • Develop appropriate sampling plans, test protocols, and quality standards for raw materials, work in process, and finished goods as required for new product development activities
  • Support new product launch activities, including pilot lots.
• Coordinate and oversee instrument acquisition and validation activities
  • Participate in budgetary review and capital expenditure process for new instrument requests.
  • Participate in test equipment validation planning, execution and implementation.
  • Support validation activities related to design changes or technology refresh.
• Lead investigation and resolution of Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory deviations, and invalid assay results.
• Ensure timely completion and effectiveness of laboratory investigations and associated CAPAs.
• Ensure QC operations maintain inspection readiness for FDA, ISO 13485, customer, notified body, and internal audits.
• Lead responses to QC-related audit observations and regulatory findings.
• Oversee stability testing programs including real-time, accelerated, and in-use stability studies.
• Monitor stability trends and support shelf-life assignments and extensions.
• Follow company policies and practices as outlined in the Handbook, SOPs and WIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job functions in the department.
• Demonstrates flexibility to support business needs, including occasional extended work hours during investigations, audits, validations, new product launches, or critical business activities.
• Willingness to accept changes in work from day-to-day within reasonable and expected boundaries
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Biology, Clinical Laboratory Science, or related discipline required.
• 8+ years of laboratory, quality control, or analytical testing experience in a regulated medical device, IVD, biotechnology, or pharmaceutical environment.
• Minimum 3-5 years of people leadership experience required.
• Demonstrated experience with FDA QSR/QMSR, ISO 13485, and cGMP requirements.
• Experience with assay validation, method transfers, statistical analysis, and root cause investigations.
• Experience supporting FDA, ISO, customer, or notified body audits preferred.

Minimum Physical Requirements:

• Remain seated in a normal position for extended periods of time up to 8 hours
• Walk, stand, and move about at various times in the workday
• Reach up and out with hands and arms
• Talk and hear; verbally express information
• Keyboard, 10 keys for extended periods
• Repetitive motion; hands
• Lift up to 25 pounds and carry at a distance of 10 feet