Director, Quality Engineering and Quality Control

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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 impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We are focused 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 who share this passion to join our team.

 

We currently have an opening for a Director, Quality Engineering & Quality Control. This position will be responsible for ensuring there are compliant manufacturing processes and has oversight for the Quality Control activities, for 3 business units (Cardiac Assist Hardware, Cardiac Assist Disposables, Cardiac Surgery and Vascular Interventions) related to Production and Process Controls, incoming, In-process and Finished device acceptance testing and release as well as Calibration.

 

Essential 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,
• Manages the Calibration department ensuring compliance standards and practices are maintained.

Lead        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 and ensures audit readiness,
• 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

•           - 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, Gauge R&R and product transfers with Suzhou manufacturing facility.

•            - Ensures that all project related commitments are achieved on schedule and within the budget.

•            - Represents the department in various management and project briefings and communicates with direct and indirect reports concerning matters concerning effective operation of the department.

•            - Generates, reviews, and approves CNs (Change Notices) Device History Records, and NCMR’s.

 

Required Knowledge, Skills and Abilities

• A Bachelor’s degree (or equivalent) In Engineering, Science or related field and/or related experience is required.

• A minimum of 10 or more years of experience in quality control, quality engineering and production quality 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 and communicate effectively across departments, with plant management and leadership teams.
• Demonstrated leadership ability and experience managing a cross-functional technical 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,