Supervisor, Quality Control Manufacturing

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

This position is responsible for supervising Quality Control activities related to In-process and Finished Goods materials for Cardiac Assist Hardware and Disposable for the Quality Control department.  This role is crucial in overseeing that the highest standard of quality products are produced, tested and released in accordance to the applicable procedures. Ensures compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP) and regulatory standards.

The position is onsite and it manages a team of Quality Control Inspectors.

Job Responsibilities and Essential Duties

• Supervises the activities of the QC inspectors on the manufacturing floor(s) and ensures the timely testing, floor audit inspections, review of test results and disposition of in process and finished goods materials.
• Perform product release activities in a timely manner.
• Initiates Ship Holds as needed to contain material with potential patient safety concerns.
• Addresses Corrective Actions and Preventive Actions (CAPA) and audit finding for area of responsibility.
• Participate on teams to improve current processes or bring new processes or product lines in-house.
• Provide feedback/guidance to study coordinators members when writing validation protocols instructions.
• Coordinate the test activities and review of  engineering evaluation studies and validations to provide results to the engineers in a timely manner.
• Authority to segregate and quarantine products and to release goods to inventory from quarantine.
• Assures training of direct reports is accurate and up to date for the jobs being performed.
•  Conduct training and refresher training as needed.
• Ensures adequate QC staffing and capacity is in place to achieve production schedules and to address priorities.
• Responsible for salary administration, conducting performance appraisals and development plans for direct reports. 
• Generate and review Change Notices as assigned.
• Generate and writes NCMR rework instructions for non-conforming material.
• Interact with all levels within quality and operations and external governing bodies during audits.

Required Knowledge, Skills and Abilities

• A Bachelor of Science degree in Science, Engineering, or equivalent combination of education and related experience is required.
• A minimum of 3 years of experience in quality control, auditing, and/or directing the activities of QC technicians in a regulated industry (FDA, ISO, etc.) is required.
• A minimum of 5 years of experience in quality control, quality assurance, and supervising quality control employees.
• Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Quality Manager is ideal.
• Must have effective leadership, organizational and communication skills to interact with other departments and direct/supervise the Quality Control staff.
• Must have demonstrated analytical and problem-solving skills and the ability to assess and summarize critical technical results in written reports.
• Proficiency in basic statistics and prior experience with data base management systems is preferred.
• Must demonstrate the ability to execute test method validations as written and provide feedback to Engineering.
• Knowledge of SAP, Information Mapping, and presentation skills are desirable.
• Proficiency in MS Office or equivalent software applications. #LI-YA1

The base salary for this position is a min of $90,000 and a max of $115,000 plus 8% Annual bonus.

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.