Reporting to the RA/QA Manager, GI and based in our European headquarter location, the Quality Assurance Engineer is a high visibility role within our Gastroenterology (GI) QA/RA Team. The Quality Assurance Engineer will ensure product and process conformity to requirements and documentation of the Quality Management System and applicable standards and regulations.
- Complaint review: review and approve complaint records before closure, address any gaps with the complaint handling unit (Service-Helpdesk)
- Complaint investigations: support Service Helpdesk in more complex complaint investigations. Bring CAPA worthy complaints or trends to the CAPA meeting.
- New Product Design & Development and Design Changes / Engineering Changes related QA review: Review and approve documentation. Release new/changed products and processes. Perform inspections (e.g. First Article Inspections, DHR inspections) before and after product / process release
- Internal & Supplier Audits: (Co-create) audit plans, schedules, communication. Perform and document audit results as (Lead)-auditor. Follow-up on nonconformities and other findings (e.g. through IA-actions or CAPA) with internal process owners and suppliers.
- External Audits: co-host external audits with QARA team. Subject Matter Expert and auditee for processes/ procedures owned by QA
- Co-maintain documentation for processes and procedures owned by QA, with peers in other Laborie sites / QMS’s with whom we share (harmonized / global) procedures and functions.
- QA lead, train and coach persons performing QA related tasks in catheter production locations Switzerland (Attikon) and USA-New Hampshire (Portsmouth). Perform more complex QA tasks remote and via travel.
- Inspect DHR records of the contract manufacturer in Enschede on a regular sample basis.
- Perform process (re-)validations and QMS Software (re)validations as required.
- Review and approve documented product-nonconformities (NCRs) before closure. Verify segregation and blocking of NC product and verify that released for use or reworked materials/components meet all specifications. Bring suggestions for concessions to the RA (Regulatory Affairs) colleagues for decision and justification. Chair periodic NCR meetings to ensure process NCR records are closed in due time. Bring CAPA worthy improvement needs to avoid recurrence of NCRs to the periodic CAPA meeting and follow up such improvements with the process owners.
- Collect quality data and trending data for Management Review and Post Market Surveillance: from complaints (complaint rates, failure mode statistics), in-production product-nonconformity records (NCR rates, failure mode statistics), and supplier deliveries (supplier NCR rates).
- Supplier QA: Perform supplier risk classification, qualification, approval/release, monitoring, scorecards and periodic (re)evaluation. Address repeat supplier NCRs and adverse trends with suppliers (e.g. SCAR’s, supplier-complaints).
- Maintain UDI (USA FDA, EU) databases upon changes
- 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
- Participate in process and product risk assessments (e.g. pFMEA, dFMEA): provide input and follow through with owners on implementation of documented risk mitigation controls in product realization processes.
- Support product recalls: gathering information on affected products (e.g. serial number, lot, or batch ranges, customer list), verify documented execution of recall to plan by involved functions (e.g. Operations, Marketing, Field Service, Sales, Distributors).
- 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 your manager (Director QA/RA)
- Participate in global and local project work streams to represent QA GI (e.g. SAP project, e-QMS, Laborie Procedure Harmonization, EU-MDR)
- University degree at Bachelor or Master level. A Technical/Engineering/Physics/Biomed degree is preferred.
- 5 years’ experience in QA Engineering in an ISO 13485 (preferred) or ISO 9001 certified organization.
- Experience in QA and any other functions covers: Production, Design Transfer, Purchasing Controls, Complaint Handling, Warehousing, Design/Engineering changes, Design controls.
- Experience with Risk Management (e.g. ISO 14971 or other industry standard) is preferred.
- Experience with (Medical Devices or other industry) Electrical Equipment and a basic understanding of related IEC product safety standards (e.g. Medical Devices IEC 60601-1 series) is preferred – ability to work with R&D and QA-IEC experts within Laborie.
- Experience with Medical Devices quality management systems standards is preferred (e.g. ISO 13485, USA QSR)
- 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. Tunes to company priorities and has a serving attitude to help others to make their time 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 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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