Manager, Quality Assurance

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 Summary

The Manager, Quality Assurance & Regulatory Affairs is the Management Representative for the quality system, responsible for maintaining a compliant quality system, implementing new and updated product-related regulatory requirements of applicable markets and jurisdictions, ensuring full audit readiness of the organization, and leading a quality team.

This role requires strong leadership, technical expertise in quality assurance and regulatory affairs, and the ability to collaborate effectively with cross-functional teams. As such this role requires fully on-site, in person committment.

The Manager, QA & RA will provide regulatory guidance on business matters for the US and world markets, liaise with regulatory bodies, ensure regulatory compliance, and manage all regulatory submissions & registrations.

Timely data analysis and presentation to UCS management is critical to success in this position.

Job Functions

• Develop, administer, and maintain the quality management system (QMS), including the Quality Manual, QMS processes, and all documents & records that support the QMS.

o Maintenance, review, and implementation of standards and regulations affecting the product and the QMS.

o Analyze and recommend appropriate changes to procedures to respective managers.

o Audit existing and new procedures for compliance based on ISO, FDA, and cGMP requirements.

o Set up and maintain the documentation system and its controls.

• Serve as the Management Representative according to FDA, ISO 13485, and other regulatory requirements.

• Coordinate and administer third-party quality audits and regulatory inspections, including schedules, communication, reports, and tracking follow-up actions.

• Lead projects that impact the Quality Management System

• Report on progress against schedules, milestones, and project goals

• Respond to internal and external audit findings and assist in planning, corrections, and prevention as needed.

• Manage all aspects of audits by external agencies.

o Responsible for ensuring compliance of local audit support procedures to external regulations, standards, and corporate procedures.

• Responsible for ensuring record retention policies related to audit records are followed.

• Complaint handling/Vigilance responsibility – maintenance of vigilance system in compliance with relevant regulations, Medical Device Regulation (MDR) evaluation and reporting, complaint trending, and PMS

activities

• Product release – ensuring product release in accordance with quality and regulatory requirements.

o Responsible for effectively managing all ship holds, recalls, field actions management, and non-conforming materials and product disposition.

• Oversee the Corrective Action Systems, including Customer Complaints, Corrective and Preventive Actions, and Non-Conforming Products.

• Maintain the Corrective and Preventive Action (CAPA) program, including tracking the status of open actions, receiving and reviewing responses, working with departments to ensure timely completion, and periodic

reports and metrics.

o Monitor, evaluate, and assign corrective actions to appropriate departments for completion.

o Verify by auditing the effectiveness of corrective actions.

o Provide reports on problem areas to Management on a regular basis.

• As needed, provide regulatory guidance on business matters for the US and world markets

• Provide regulatory guidance on business matters for the US and world markets, liaise with regulatory bodies, ensure regulatory compliance, and manage all regulatory submissions & registrations.

• Responsible for continuous improvement, internal audits, and third-party audits for certifications and investigations, and supports manufacturing, process validations, engineering, and supply chain.

• Supplier controls, including reviewing, approving, and monitoring suppliers and supplier performance against any internal or customer requirements.

• Report ongoing activities to Management and keep the Company's continuous improvement efforts on track.

• Work with UCS departments to improve their processes.

• Oversee, maintain, and improve the Company's training program and employee competency assessments.

• Manage multiple quality programs/processes at UCS, including the internal audit program, change management, and regulatory updates (e.g., gap analysis and implementation).

• Input into product design and development.

• Setting, along with the site Managing Director, QA compliance objectives and ensuring that targets are achieved.

• Identify relevant quality-related training needs.

• Keep current on all applicable ISO, FDA, and cGMP requirements.

• Additional duties as required.

Required Knowledge, Skills and Abilities

• Bachelor's Degree or equivalent.

• In-depth knowledge of ISO 13485 and FDA 21CFR820 requirements. Knowledge of EU MDR is beneficial.

• Audit Certification required.

• Must be experienced in conducting third-party and internal audits on a regular basis.

• Knowledge of FDA regulations regarding Class 1 devices and FDA reporting procedures.

• Medical device or comparable highly regulated industry, pre- and post-market regulatory experience, global knowledge of quality requirements

• Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a culture of quality and compliance.

• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, regulatory agencies, and external stakeholders.

• Strong computer skills, including MS Office applications (Word/Excel) and Microsoft Project are required.

• Proficiency in relevant software applications (e.g., document management systems, quality management systems) is a plus.

• Analytical mindset with strong problem solving skills.

• High level of attention to detail and accuracy.

• Certification in ethical practices or completion of ethics training programs is a plus.

Quality Requirements

• Build Quality into all aspects of work.

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (As applicable to your 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

• Duties are mainly performed in an office environment.

• Ability to complete assignments and utilize computer and telephone equipment and other related office accessories/devices.

• Hearing necessary to receive and reply to outside contacts and employees. Ability to speak clearly to communicate with outside contacts and employees in person and on the telephone. Must be willing to work in a

sitting position for long periods of time.

• Ensures environmental consciousness and safe practices are exhibited in decisions.

• May work extended hours during peak business cycles.

• While performing the duties of this job, the employee is frequently required to stand, walk, and sit.

• Some bending, stooping, reaching, and lifting (up to 50 pounds) is required.

• Willingness to frequently move to various locations within and outside of the building.

• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

• Some travel (both domestic and international) required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervision/Management Of Others

Responsible for the development and management of personnel and programs within the Oldsmar Quality department.

Internal and External Contacts/Relationships

• Managing Director, Leadership team, Operations, Finance and Research & Development.

• Head of QA Operations, SW, VP QRC Surgical Workflows

• Interaction with cross-functional departments

• Interaction with external customers and representatives from regulatory agencies

Disclaimer

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position, it is not an exhaustive list of all responsibilities, duties and skills required for the position.

Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

Continued employment remains on an "at-will" basis.

Salary range: $112k - $141k + bonus targeted at 15% (depending on overall company performance)

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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.