Reporting to the Director QA/RA, GI and based in European headquarter location, the RA/QA Manager is a high visibility role within our Gastroenterology (GI) RA/QA Team. The RA/QA Manager will ensure product and process conformity to regulatory requirements of all markets (i.a. EU, USA, Japan, Canada, Brazil, Australia, Taiwan). The RA/QA Manager will also ensure documentation conformity to applicable regulations, related standards and quality management systems.
- Responsibility for GI products of sites in the Netherlands, Attikon (Switzerland) and Portsmouth (New Hampshire, USA).
- Line manager responsibilities for QA/RA team members (QA Engineer Amsterdam/Enschede, QA/RA Associate Enschede, QA/RA Engineer USA)
- Delegate, coach and manage all GI related RA work with other QA/RA team members in GI and in other Laborie businesses or global functions. Perform senior RA engineering work yourself as required. Manage time lines and output results for RA deliverables
- Technical Documentation (Tech File / Design File, 510(k) file, etc.) owner: keep TD up to date with Design Changes and Process Changes. Collect/review/build TD for newly developed products. Work with Notified Bodies for annual surveillance TD reviews and lead/coordinate improvements needed with involved functions (Clinical, R&D, Operations, Marketing, etc.)
- Product registrations/licenses and Site registrations with all regulatory authorities and EU-notified bodies. Direct for EU, USA (e.g. 510(k) filing, UDI registration) and via distributors and/or other Laborie RA colleagues for other countries.
- Quality Agreements: Ensure that regulatory responsibilities and quality assurance are covered in quality agreements with contract manufacturers and distributors
- MDR / event reporting: for complaints classified as potential safety issue by Service Helpdesk or QA, determine reportability and perform reporting as required to all affected countries. Work with management to tune communications to authorities, related public databases and customers
- Recalls: determine the need for recall from events or incidents. Lead and document the recall plan and customer letters. Submit plans to regulatory authorities as required. Lead/chair the recall action implementation team to meet all regulatory requirements with Operations, QA, R&D, Field-Service, Marketing, etc. to execute on the plan.
- Risk Management files: owner of risk management procedure, and plan and report (e.g. FMEA) per device. Ensure conformity to regulations (e.g. EU MDD/MDR, RoHS, REACH, USA 21 CFR), ISO 14971, and other ISO (e.g. SW-Lifecycle Management, Biocompatibility) and IEC standards to mitigate all risks to acceptable level or acceptable benefit/risk ratio. Chair product risk assessments for new product designs, design changes, events/incidents, process changes, QMS software changes.
- Define and document regulatory and product quality input requirements for new product design or design changes. Ensure that any mitigations required per risk file are documented as design input requirements
- Review all new product design files and design change documents from an RA perspective and from a TD perspective.
- Significant Change Notifications: Notify regulatory authorities and EU-notified body for significant changes in products or processes.
- Create documents owned by RA in new product design with involved functions (e.g. RA strategy in line with Marketing Strategy, Essential Requirements Checklist EU, List of applicable standards to fulfil regulatory requirements, Risk File, CER)
- Post Market Surveillance: Compile annual PMS report with input from Laborie Clinical (Literature, events, etc.), Service (compliant trending) and Manufacturing (nonconforming product trending) and document conclusions and actions needed. Drive follow-up on actions with involved process owners.
- Identify impact of new/updated regulations and standards for the products and processes/procedures and lead/coordinate required updates to TD and QMS with involved functions
- Internal audits and audits on contract manufacturer in Enschede: Create IA plan, schedule, agenda with QARA team. Lead auditor / co-auditor as per agenda.
- External Audits: host external audits with QARA team. Subject Matter Expert and auditee for processes/ procedures owned by RA
- Co-maintain QMS documentation for processes and procedures owned by QA and RA, with peers in other Laborie sites / QMS’s with whom we share (harmonized / global) procedures and functions.
- Document justifications for releasing any products for distribution under concessions or deviations.
- Bring CAPA worthy improvement needs to avoid occurrence or recurrence of noncompliance to regulations or standards to the periodic CAPA meeting and follow up such improvements with the process owners.
- CAPA process: support QARA team to drive CAPA planning, containment actions, implementation and effectiveness checks with process owners. Perform inspections for containment, verify and approve implementation of actions, plan and perform effectiveness checks
- Supply regulatory data and information from Risk Management and PMS for Management Review.
- Maintain awareness and culture for quality and compliance in the organization, at all levels of your interaction. Raise any (potential) concerns to your manager.
- Bring any information of (potential) product non-conformity after delivery (e.g. potential complaints) to the Service-Helpdesk to file as a feedback/complaint
- Bring suggestions for preventive action to your manager.
- Work within policy, strategy, priorities and guidance of management
- Participate in global and local project work streams to represent RA GI (e.g. SAP project, e-QMS, Laborie Procedure Harmonization, EU-MDR, Acquisitions/Integrations)
- Support and back-up QA and RA colleagues as required (e.g. workload peaks, vacation or absence periods)
- University degree at Bachelor or Master level. A Technical/Engineering/Physics/Biomed degree is preferred.
- 5 years’ experience in RA Engineering in Medical Device class IIa or higher organization, with in-depth experience throughout the responsibilities listed in this job description.
- 2 years’ experience in manager or team leader role. Additional QA Engineering or QA Manager experience is preferred.
- Experience with Medical Devices quality management system standards (e.g. ISO 13485, USA QSR). Experience with MDSAP program and certification is preferred.
- Experience as quality auditor. Lead auditor qualifications and ISO 19011 Quality System Auditor training/certification is preferred.
- Likes to work both independent, with people, and in teams, with local and global peers and cross-functional colleagues.
- Soft skills and personality: Influential skills and pervasive, tenacious, firm. Knows to build and balance respectful mutual relations. Knows when and how to escalate issues. Team player. Knows to give people relative freedom for ‘how to do things’ while keeping control on the ‘what must be met and achieved’. Project management skills. Positive change agent. Sets and tunes to company priorities and has a serving attitude to help others to make their time lines. Thrives in a complex international ‘networked organization’ with horizontal peers, high organizational change dynamics, and project related reporting lines.
- Fluent in English, verbal and in writing.
- Travel to Switzerland may be required on a regular basis (e.g. once per quarter, or more frequent in case of projects). Travel to USA less frequent.
- Training may be required. Positive attitude to invest some own time in further training and development as required.
- Must work well in a dynamic environment and be able to recommend and implement process improvements, work independently and handle multiple tasks simultaneously.
LABORIE is focused on creating new and exciting career opportunities and professional challenges for existing and prospective employees. In addition to working with great people, we promote a supportive work culture and offer competitive compensation, comprehensive benefits programs, as well as many opportunities for career advancement.
At LABORIE, we take the long view of success. We are privately owned by Patricia Industries, a part of Swedish-based InvestorAB owned by the Wallenberg Family. Our owners value sustainable and profitable growth.
LABORIE is an industry-leading innovator, manufacturer and supplier of medical technologies and devices, with headquarters in the United States, Canada and the Netherlands. We enjoy a strong diversity of talent with 650 global employees. We have grown significantly over the past several years and continue to invest in new technologies, companies and regions.
LABORIE takes great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. We are focused on educating healthcare providers and their patients on the latest solutions in Urological and Gastrointestinal health.
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