Quality Control Manager

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships

POSITION SUMMARY

The Manager, Quality Control position ensures the products are compliant to internal and external standards, safety regulations, and customer expectations by developing processes, inspecting outputs, and managing QC teams. Key responsibilities include managing and mentoring staff, analyzing data, and mitigating defects.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes.
• Manage inspectors and inspection processes of medical devices. (1st shift)

• Carry out supervisory responsibilities including training, planning, directing, mentoring and appraising performance.
• Participate in the management of the non-conformance system and efforts toward continuous process improvement and business automation.
• Responsible for the periodic review of inspection processes and procedures.
• Supports technical aspects of the inspection process, including investigation of complaints.
• Supports manufacturing operations in product and new product development

• Ensure the Quality Control department complies with 21CFR820, ISO 13485, MDSAP and MDR 
• Responsible for the application and maintenance of quality standards and the quality management system as they apply to products and services 

• Support audits to demonstrate compliance of quality control systems
• Perform other TransMedics tasks and duties as required

• Lead and support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate business growth 

MANAGEMENT RESPONSIBILITIES 

• This position manages the following positions on a daily basis. 
• This position has responsibility for Group Leads and Inspectors in various roles within the
• QC department, including but not limited to Incoming Inspection, Cleanroom and Equipment and Service.

PHYSICAL ATTRIBUTES

• Physical Activities:
  • Mobility: Walking, standing, sitting, balancing, stooping, kneeling, crouching, reaching, pushing/pulling, lifting, carrying. 
  • Fine Motor Skills: Grasping, fine manipulation, feeling. 

• Sensory Abilities:
  • Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus. 
  • Hearing: Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions. 
  • Other Senses: Ability to perceive smells, tastes, or textures as relevant to the job. 

• Environmental Factors:
  • Temperature: Exposure to hot or cold environments. 
  • Noise: Exposure to loud or distracting noises. 
  • Hazards: Exposure to chemicals, machinery, or other potential dangers. 

• Other Considerations:
  • Repetitive Tasks: Frequency and duration of repetitive movements. 
  • Mental/Emotional Demands: Stress levels, ability to handle change (tasks, workload).
  • Equipment Use: Ability to operate specific tools or machinery. 

• Safety: Ability to work safely and follow safety procedures.                                           

MINIMUM QUALIFICATIONS                                                       

• At least 5 years’ experience in managing direct reports in a Quality Control function
• Manufacturing and sterilization (including cleanroom) experience

PREFERRED QUALIFICATIONS

• BS in Engineering or Life Sciences or equivalent combination of education and experience
• Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations. Experience with MDR a plus. 
• Knowledge of statistical techniques.
• Proficient in MS Office Suite (i.e. Word, Excel, PowerPoint, Access).
• Must be team-oriented and collaborative
• Excellent interpersonal skills demonstrating the ability to work with others in a professional positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proven Ability to provide logical, in-depth analysis of a problem or situation