Manager, Quality Operations

1 month ago

Detroit, Michigan, United States Getinge Full time

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.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

We focus on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals to join our team.

We currently have an open position for a Manager, Quality Operations, CA. This position is responsible for ensuring there are compliant manufacturing processes and has oversight for the Quality Control activities, for Cardiac Assist Hardware & Disposables, related to Production and Process Controls, incoming, in-process and Finished device acceptance testing and release. This role will lead and manage the Quality Operations teams to ensure the highest standards of product quality and regulatory compliance in the manufacturing, and distribution of medical devices. This role is crucial in overseeing the implementation of quality systems, driving continuous improvement initiatives, and ensuring compliance with all relevant regulatory standards. This role will be responsible to ensure new product design transfer and design change activities are executed to the plan and compliant. Oversees sites Master Validation plan for equipment and processes.

Job Responsibilities

  • Manages the following:
  • Quality Control activities related to In-process and finished device acceptance testing and release,
  • Supports and Partners with Incoming Quality Control. Ensure compliance standards and applicable government regulations,
  • Supports the Calibration department ensuring compliance standards and practices are maintained.
  • Provide mentorship, training, and performance management for the quality team members.
  • Leads the following:
  • Production and Process Controls monitoring and improvements,
  • KPI reporting,
  • Investigations of process and product non conformances including NCMR's (Nonconforming Material Reports) and CAPA's,
  • Kaizen and GEMBA walks,
  • Communication and coordination activities related to the release of final product, including ship holds and field actions,
  • Quality Management System Audits,
  • Front and/or backroom lead / support for all internal and external audits,
  • Remediation activities including test method validation, process validation and re-validation, and preventive measures
  • Collaborates to set-up and maintenance of Manufacturing Control Plans and pFMEAs.
  • Organizes activities and implements improvements to efficiency within the department to ensure that inspection and testing is executed in a timely manner.
  • Supports New Product Development establish manufacturing requirements and inspection criteria.
  • Ensures consistency for test methods, inspections, and supporting Gauge R&R/ test Method Validation studies.
  • Ensure accurate and timely documentation of quality activities, including inspection records, audit reports, and CAPA documentation. Oversee the development and implementation of incoming, in-process, and final inspection procedures.
  • Prepare and present quality metrics and reports to senior management. Represents the department in various management and project briefings and communicates with direct and indirect reports concerning matters concerning effective operation of the department.
  • Ensure robust design control processes, including Design Verification and Validation (DV&V), risk management, and process validation.
  • Ensure effective use of statistical process control (SPC) and other quality control methodologies.
  • Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, Supplier Quality, and Supply Chain, to ensure quality is integrated into all aspects of product development and production.
  • Oversee the maintenance and continuous improvement of the Quality Management System (QMS). Ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485, MDSAP) and internal quality policies and procedures.
  • Manage internal and external audits, including FDA inspections, ISO certification audits, and customer audits. As the SME for the Quality Operations and Production/ Manufacturing areas.

Required Knowledge, Skills and Abilities:

  • Bachelor's degree (or equivalent) In Engineering, Science or related field and/or related experience is required. Minimum 7 years of experience in quality control, quality engineering or related functions In a FDA regulated industry or ISO certified organization is required.
  • ASQ, CQE (Certified Quality Engineer), CQM (Certified Quality Manager) or CQA (Certified Quality Auditor) is a definite plus.
  • Must have demonstrated the ability to analyze and solve complex problems; decision-making and communicate effectively across departments, with plant management and leadership teams.
  • Demonstrated leadership ability and experience managing & developing a cross-functional technical and professional level support staff.
  • Must demonstrate effective influencing, change management skills and achievements in managing process improvements.
  • Must demonstrate ability to manage projects and multiple priorities and be able to organize activities and drive results.
  • Proven background in statistical techniques and programs, as well as Microsoft Office Products such as Word, Excel or equivalent software applications is preferred.
  • Proven background in Quality, Risk Management and Lean Six Sigma principles and tools: including DMAIC, GEMBA, Kaizen, PFMEA's, Ishikawa Diagrams, and 5 Why's.

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.

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