Supplier Quality-SW Infection Control Consumables Manager

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 Supplier Quality – Surgical Workflow-Infection Control Consumables (SWICC) is responsible for strategically leading and executing the SWICC-level supplier quality management program across all sites, including Healthmark (Fraser, MI), Steritech (Denver, CO), LTA Medical (Paris, France), Quadraline (Derby, UK) as well as any future SWICC sites, lead supplier qualification, auditing, performance monitoring, and ongoing compliance. This role is focused on supplier quality systems and compliance. Product quality requirements and specifications are owned by R&D/Engineering; this position acts as the key quality contact between suppliers and internal teams to ensure suppliers are qualified, audited, and held accountable for their quality system commitments.

The Manager, Supplier Quality leads a team of Supplier Quality Engineers (SQEs) and may also lead one or more Supplier Quality Manager(s); manages cross-site supplier quality activities, and partners with Procurement, Operations, R&D, and site QRC teams to mitigate supply chain quality risk and drive continuous improvement.

Job Responsibilities and Essential Duties:

• Establish a word class supplier management program within the SWICC Business Segment.
• Qualify, approve, and perform periodic re-evaluation of vendors and service providers as required per the SWICC supplier management program, in compliance with ISO 13485:2016 and other applicable regulations (e.g. EU MDR).
• Develop and maintain the risk-based supplier qualification process, including quality questionnaires, desktop assessments, and on-site capability evaluations; maintain the SWICC Approved Supplier List (ASL) and all associated vendor management files.
• Plan and conduct scheduled vendor audits to assess compliance with FDA, ISO 13485:2016, internal QMS requirements, and applicable regulatory standards; manage audit scheduling, observation documentation, findings reporting, and verification of corrective action effectiveness.
• Plan and conduct For-Cause audits to address critical vendor management concerns resulting from changes in vendors' processes, previous audit findings, recurring non-conformances, suspected vendor-related issues, or escalated risk events.
• Participate as a member of the internal audit team, applying auditing principles and procedures to routine and for-cause assessments of cGMP/QMS compliance within the SWICC quality system.
• Ensure Supplier Quality oversight regarding the disposition of supplier caused non-conformances; coordinate with Operations and site QRC teams on quarantine, rework, return, and replacement activities.; ensure systemic non-conformance patterns are addressed through corrective action.
• Issue, manage, and close Supplier Corrective Action Requests (SCARs); facilitate root cause analysis with suppliers, verify effectiveness of corrective actions, and escalate non-responsive suppliers as required; maintain program-level SCAR metrics and drive accountability at the supplier executive level when necessary.
• Develop and maintain supplier scorecards and performance dashboards covering quality, delivery, and responsiveness KPIs; prepare and present supplier performance trends at QRC and Management Review forums; translate performance data into strategic sourcing and supplier development recommendations for leadership.
• Develop supplier improvement plans for underperforming or strategically critical suppliers to mitigate risk to SWICC operations.
• Review, negotiate, and maintain Quality Agreements (QAs) with vendors providing materials, components, and services that impact cGMP operations; ensure agreements are executed, enforceable, and periodically reviewed.
• Represent Supplier Quality in New Product Introduction (NPI) and product transfer projects; ensure supplier approval and quality system readiness are in place prior to commercial launch. Product quality requirements and specifications remain the responsibility of R&D.
• Review and communicate supplier-initiated requests for engineering changes or material substitutions; evaluate for quality system impact and route to R&D and Operations for technical disposition.
• Collaborate with Procurement to ensure supplier performance data informs sourcing decisions, contract renewals, and re-qualification triggers.
• Facilitate changes to supplier status (e.g., approval, restriction, disqualification) and ensure all required documentation and activities are completed.
• Author, review, and revise Supplier Quality procedures, work instructions, and associated records/documentation within the SWICC QMS.Complete trending and analysis of supplier defects, recurring problems, and corrective actions; use data to prioritize audit focus and supplier development activities.; present program-level trend summaries to QRC leadership and functional stakeholders on a recurring basis.
• Actively participate with Procurement, Operations, and R&D to continuously improve supplier evaluation, risk assessment, and mitigation processes across the SWICC segment.
• Travel to supplier locations to conduct audits, facilitate resolution of quality problems, and support qualification activities as required.
• Lead, coach, and develop a team of Supplier Quality Engineers (SQEs) across SWICC sites (anticipated team size: 3–7 FTEs); team may include one or more Supplier Quality Manager(s) with direct report SQEs.
• Set performance expectations, support professional development, manage workload prioritization, and foster a culture of quality and accountability.
• Define organizational structure, staffing needs, and role scope for the Supplier Quality function within SWICC.
• Partner with the Director, QRC to secure headcount and build team capability aligned to segment growth.
• Serve as a key contributor to SWICC QRC strategic planning, budget development, and annual goal setting; represent Supplier Quality priorities in segment-level business reviews.
• Assist in establishing and ensuring completion of department and segment-level goals aligned to SWICC QRC strategic objectives.
• Ensure quality compliance throughout all supplier quality activities and affected areas.

Required Knowledge, Skills and Abilities:

Detailed knowledge of:

• Global medical device regulations (FDA 21 CFR 820, ISO 13485), including UK and EU requirements ISO 13485:2016, and ISO 14971:2019, with specific focus on supplier control requirements (21 CFR 820.50 / ISO 13485 Clause 7.4).
• Working knowledge of EU MDR 2017/745 supplier-related obligations and applicable MHRA (UK) requirements; experience with post-Brexit quality system expectations is a plus.
• Experience planning and conducting supplier audits (scheduled and for-cause) in a medical device environment; ISO 13485: 2016 or ISO 9001: 2015 Lead Auditor certification required.
• Familiarity with the sterile processing and infection control product landscape, including applicable standards such as ISO 11607: 2019 (sterile packaging), ANSI/AAMI standards, and related consumable device supply chain considerations.
• Experience with Advanced Product Quality Planning (APQP) and PPAP (Production part Approval Process) as related to the qualification and FAI (First Article Inspection) of vendor provided products, raw materials, and components.
• Strong data analysis skills; ability to build and interpret supplier quality metrics, trend analyses, Pareto charts, Statistical Process Control (SPC), and performance dashboards using Excel, Power BI, or equivalent tools.
• Experience authoring and managing quality agreements, audit reports, SCARs, CAPAs, and supplier qualification records within an eQMS/QMS environment.
• Proficiency with QMS/eQMS platforms (e.g., Trackwise, OneDoc, MasterControl, Veeva Vault, or equivalent), Product Design Lifecycle Management (PDLM) Tools, and ERP systems (e.g., SAP or equivalent).Demonstrated senior people's management capability: ability to lead, develop, and hold accountable for a team of quality professionals in a multi-site, matrixed environment.
• Demonstrated ability to build and scale a functional quality program from early-stage infrastructure through full operational maturity; experience designing team structure, workflows, and governance frameworks.
• Ability to influence without direct authority across cross-functional and cross-cultural teams (US, France, UK).
• Strong written and verbal communication skills; ability to present quality risk assessments and performance data clearly to senior leadership and external stakeholders.
• Supplier-facing negotiation and escalation skills; able to maintain productive long-term supplier relationships while enforcing quality and compliance requirements.
• Proven organizational and project management skills; ability to manage multiple concurrent audit programs, qualification activities, and corrective actions with competing priorities.
• Experience contributing to or leading supplier quality integration activities related to mergers, acquisitions, or manufacturing site transfers in a regulated medical device environment.

Minimum Requirements:

• Bachelor's degree in engineering, Medical Devices, Life Sciences, Materials Science, or a related technical discipline; advanced degree strongly preferred.
• Demonstrable senior level quality experience within a regulated medical device environment, with substantial focus on supplier quality management.
• Direct experience with ISO 13485: 2016 and FDA 21 CFR Part 820 supplier control requirements.
• Demonstrated experience conducting supplier audits (scheduled and for-cause).
• Experience with Class I and/or Class II medical device products; consumables, disposables, or SPD-related product experience preferred.
• Prior experience managing or mentoring quality staff preferred.
• Demonstrated experience building or significantly maturing a supplier quality function, including development of program infrastructure, procedures, and performance management systems.

Preferred Qualifications:
• Familiarity with SPD (Sterile Processing Department) consumable products and infection control supply chains.
• Knowledge of EU MDR 2017/745 and post-Brexit MHRA requirements as applied to supplier control.
• Experience working within a global medical device organization with manufacturing sites in the US and Europe.
• Experience supporting quality integration activities in M&A, site consolidation, or manufacturing transfer programs.
• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification.

Quality Requirements:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:
• Environmental/Safety/Physical Work Conditions
• Standing and/or sitting for long periods of time.
• Travel required (estimated 15–35% annually), including domestic and international travel to supplier facilities, SWICC manufacturing sites, and industry events (US, Europe, Asia, UK, and other supplier locations as needed).

Supervision/Management of Others:
• Directly manages a team of Supplier Quality Engineers (SQEs) across SWICC sites 
• Responsibilities include performance management, workload direction, and professional development.
• Provides direction and oversight to SQEs on audit execution, supplier qualification activities, SCAR management, and performance reporting.

Disclaimer: The above information in this description is intended to describe the general nature and level of work performed. It does not contain, nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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.