Sr. Manager, Quality Compliance

 

 

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

The Senior Manager, Quality Compliance, provides operational leadership for Quality Compliance activities at Healthmark Industries within the Surgical Workflows – Infection Control Consumables (SWICC) business, ensuring regulatory and quality system compliance for U.S. FDA Class I and II medical devices, EU MDR Class I and Class IIa/IIb devices, and similarly classified products globally.

Job Responsibilities and Essential Duties:

Develops and manages the department to assess and ensure compliance with

• FDA Quality System Management Regulations (QMSR) CFR Part 820,
• ISO 13485:2016 (Medical Device QMS Standard),
• ISO 9001:2015 (Quality Management Systems, Requirements)
• EU Medical Device Regulation (MDR), (Regulation (EU) 2017/745),
• Health Canada-Canada Medical Devices Regulations (CMDR) (SOR/98-282)),
• Therapeutic Goods Administration (TGA)-Australian Medical Device Regulations (TG(MD)R 2002),
• UK-Medicines & Healthcare products Regulatory Agency (MHRA) (UK MDR 2002 (as amended)),
• and other applicable global regulations as needed to support global portfolio expansion.

 

• This position is responsible for maintaining the Quality Management System, Internal Audit program, GetQMS Implementation, OneDoc/TrackWise Digital, GetLearning, and all Corporate OneTrack processes (complaint, CAPA, HHE, field actions), Management Review, Monthly metrics meetings, Quality planning, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations, and periodic updates. This position partners with SWICC Regulatory and QRC leaders as well as representatives/leaders from other cross-functional groups on Quality Management System improvements. The position will manage a local quality team.
• The position will lead the quality compliance team and coordinate activities to effectively maintain the quality system in accordance with the applicable regulations and standards.

• Lead the implementation and ongoing effectiveness of the Quality Management System (QMS) at the Healthmark site in alignment with corporate standards and applicable global medical device regulations.Direct day-to-day Quality Compliance activities in support of business objectives, including oversight of CAPA processes and follow-up effectiveness; management of Internal Audits, complaints, nonconforming material (NCR) processes, and supplier quality controls; facilitation of Management Review and monthly QMS metrics monitoring to ensure visibility to compliance risks; and leadership of Quality Planning activities to ensure effective implementation.
• Act as the site Management Representative, ensuring QMS suitability and effectiveness, including facilitation of Management Reviews per corporate requirements.
• Perform the role of Person Responsible for Regulatory Compliance (PRRC) as mandated by EU MDR 2017/745, Article 15.
• Provide Quality review and approval, as appropriate, for change notices, including both design and document changes, ensuring compliance with applicable regulatory requirements, quality system procedures, and change control processes.
• Lead and manage all external regulatory inspections and third-party audits (e.g., FDA, Notified Bodies, MDSAP, Health Canada, TGA, MHRA), including end-to-end inspection readiness activities, front-room and back-room coordination during inspections, and post-inspection response execution. Responsibilities include inspection preparation, hosting and facilitation, real-time issue escalation, development and submission of responses to observations (e.g., FDA Form 483, audit nonconformances), and oversight of corrective and preventive actions through to closure.

• Maintain compliance with 21 CFR 820, 803, 806, ISO 13485, ISO14971, and other applicable standards.
• Management of compliance with applicable External Standards and worldwide regulations.
• Manage