Quality Systems Manager

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Share Publication date 15 July 2024 Location Mechelen Country Belgium Workplace type Hybrid Travel percentage 0% Department Quality, Regulatory and Clinical Affairs Function type Full-time Contract type Employee Experience required

Minimum Requirements

1. Minimum 5 years of experience in medical device or diagnostics industry of which minimum 3 years in Quality Assurance
2. Significant experience in maintaining and improving Quality Management Systems;
3. Experience in performing internal audits according to the international quality standards of the IDV/medical device industry;
4. Experience of developing and delivering effective training on Quality Systems and Processes;
5. Experience in hosting and leading audits by notified bodies and regulatory authorities;
6. Experience in hosting FDA audits, would be an advantage;
7. Preferably, experience with electronic document management systems.
8. Preferably, experience with applying computer system validation (CSV) principles

Specific Professional Knowledge

1. Deep understanding of general QMS requirements of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, MDSAP, IVDR, …)
2. Deep understanding and knowledge of the QMS applied within area of scope, including but not limited to event and change management, document and record control, audits, process performance monitoring and training, software validation
3. Basic understanding of the technical aspects of Biocartis products
4. Understanding of statistical techniques
5. Trained lead auditor
6. Customer & partner centric focus
7. Methodical and process minded. Execution, results, and continuous improvement oriented.
8. Experience leading teams. Conflict resolution skills.
9. Open minded. Thrives in a changing and innovative environment.
10. Well-developed listening and influencing skills.
11. Willingness to collaborate cross-functionally in a fast paced and dynamic environment. Proven ability to demonstrate professional responsibilities by cooperating with others to achieving departmental and company goals and objectives.
12. Resilient and able to work under pressure.
13. High integrity and professional ethics.
14. Passionate, strive to make a difference.
15. Highly effective organizational and planning skills to apply daily in a multidisciplinary environment and to meet budget and timeline expectations (incl. decision making & prioritization, boundaries setting and saying no, delegating, and outsourcing tasks).

Education

Master or bachelor's degree in a technical or scientific orientation is required or similar through experience and/or training.

Key Mission

1. To ensure corporate Quality oversight over general QMS requirements, internal and external audit programs and standard management.
2. To ensure and maintain QMS accreditations and certificates and to lead inspection readiness and conduct.
3. To operate as the process owner or QA counterpart of business processes, including but not limited to process performance monitoring process, document and record control and training.
4. To ensure that these QMS processes are adequate, suitable (efficient) and effective throughout the organization.
5. To operate as business owner of the eQMS.

Accountabilities

The role includes, but is not limited to, the following accountabilities:

1. Ensure corporate Quality oversight over:

• General QMS requirements
• Internal/external audit programs
• Biocartis QMS accreditations and certificates
• Biocartis standard management
• Process Performance Monitoring
• Document and record control

Ensure QMS within area of scope is adequate, suitable and effective. Ensure QMS improvements are in line with Quality Policy and Vision. Ensure suitable process performance monitoring in accordance with Biocartis QMS, including internal audits.To ensure inspection readiness and ensure availability of appropriate site representation during internal audits and external inspections.Ensure all Biocartis activities within area of scope are executed in accordance with Biocartis QMS and such that Product Quality, i.e. patient safety, customer satisfaction and regulatory compliance is assured. These activities include, but are not limited to:

• Internal & external audits
• Quality & management review
• Quality event management within area of scope;
• Document & record control, including data integrity, within area of scope.

Accountable for Biocartis eQMSPeople and team management of the QA Systems team.Ensure on-time implementation of Quality objectives in area of scope. Ensure that respective Q KPIs are suitably defined and monitored.Ensure appropriate Quality budget within area of scope.Responsibilities

1. Providing hands-on support to activities in scope
2. Liaising with Quality leadership team and other functional leaders as needed to realize the above.
3. Liaise with regulators, notified bodies, partners and other external auditors to realize the above
4. Analyse consolidated process performance monitoring data to conclude on suitability, effectiveness and effectiveness of QMS processes as part of the Quality & management review
5. To provide Quality expertise in continuous improvement within area of scope.
6. To lead or participate in internal and supplier audit activities.
7. Take up the role of spokesperson (as process owner) during external audits, in combination with coordination of the audits (front- and backroom);
8. Address Quality-related issues about the projects/activities in area of scope.
9. Reporting and/or escalating to the appropriate governance body.
10. Leading and managing QA team members assigned to projects/activities within area of scope
11. To translate and cascade company objectives within the QA Systems team
12. To perform merit and performance reviews as per the company guidelines for the QA Corporate team.
13. To coach, evaluate and develop the QA Corporate team members. Determine training needs and ensure competence, awareness and training.
14. To facilitate team connectivity and both team and individual wellbeing at the workplace.

Profile Requirements

1. Master or bachelor's degree in a technical or scientific orientation is required or similar through experience and/or training.
2. Minimum 5 years of experience in medical device or diagnostics industry of which minimum 3 years in Quality Assurance
3. Significant experience in maintaining and improving Quality Management Systems;
4. Experience in performing internal audits according to the international quality standards of the IDV/medical device industry;
5. Experience of developing and delivering effective training on Quality Systems and Processes;
6. Experience in hosting and leading audits by notified bodies and regulatory authorities;
7. Experience in hosting FDA audits, would be an advantage;
8. Preferably, experience with electronic document management systems.
9. Preferably, experience with applying computer system validation (CSV) principles

Technical/Theoretical Knowledge, Skills, and Expertise

1. Deep understanding of general QMS requirements of different national and international quality standards (ISO 13485, FDA 21 CFR Part 820, MDSAP, IVDR, …)
2. Deep understanding and knowledge of the QMS applied within area of scope, including but not limited to event and change management, document and record control, audits, process performance monitoring and training, software validation
3. Basic understanding of the technical aspects of Biocartis products
4. Understanding of statistical techniques
5. Trained lead auditor
6. Customer & partner centric focus
7. Methodical and process minded. Execution, results, and continuous improvement oriented.
8. Experience leading teams. Conflict resolution skills.
9. Open minded. Thrives in a changing and innovative environment.
10. Well-developed listening and influencing skills.
11. Willingness to collaborate cross-functionally in a fast paced and dynamic environment. Proven ability to demonstrate professional responsibilities by cooperating with others to achieving departmental and company goals and objectives.
12. Resilient and able to work under pressure.
13. High integrity and professional ethics.
14. Passionate, strive to make a difference.
15. Highly effective organizational and planning skills to apply daily in a multidisciplinary environment and to meet budget and timeline expectations (incl. decision making & prioritization, boundaries setting and saying no, delegating, and outsourcing tasks).

Software and Database Applications

1. Experienced user of MS Office (Excel, PowerPoint, Word, Outlook).
2. Project Management Tool (e.g., MS Project)
3. Electronic Document Management system
4. Electronic Event Management system
5. ERP system (e.g. Dynamics365)
6. SQL
7. PowerBI

Legislation and Regulation

1. Knowledge of and familiarity with following guidelines and regulations:
2. GDP, GMP
3. ISO 13845, 21 CFR part 820, IVDR and MDSAP
4. 21 CFR part 11
5. Data Integrity

Languages

Fluent English (written and spoken), any other European language is considered an asset.

Interested?

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package which includes a Flexible Income Plan.

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