QUALITY MANAGER

3 weken geleden

Almere, Nederland Sinclair Voltijd

The Role

Sinclair is looking for a Quality Manager at their production site located in Almere, the Netherlands. This is one of the most important operation sites for Sinclair where Ellancé derma filler is produced under strict GMP and with aseptic procedures and cleaning rooms.

Reporting to the Plant Manager and the Head of Quality based in the UK, the Quality Manager will ensure the efficient and effective day-to-day running of the Quality department whilst adhering to regulatory compliance and achieving commercial success.

The Quality Manager will lead a quality team of 2 direct reports and 10 indirect reports.

About Sinclair

Founded in 1971, Sinclair is a global medical aesthetics organization, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.

This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.

Our Vision

Providing aesthetic excellence globally.

Our Mission

Driving the advancement of product quality and customer satisfaction, investing in innovation and people.

Our Values

Act with Integrity

Be results driven

Embrace your winning spirit

Stay ahead of the game

One team, one goal

Key Responsibilities

  • Oversee the Quality Assurance and Document Control teams.
  • Establish and maintain a strong and compliant Corporate and Local UK Quality Management System to satisfy all applicable regulatory requirements including ISO 13845, MDD, MDR, MDSAP and other standards as applicable, in support of the company’s products and services including:
  • Creation and update of standard operating procedures and controlled documents.
  • Ensure training is conducted in accordance with agreed timelines and to maintain up-to-date personnel training records.
  • Manage the progress of CAPAs and Change Controls ensuring Quality-related aspects are completed in accordance with agreed targets.
  • Processing of non-conformances and complaints, identifying root cause and implementing appropriate corrective and preventive actions (CAPA).
  • Preparation of input for Management Review Meetings.
  • Conduct internal audits and external audits.
  • Maintenance of the QMS for document management and training
  • Support in the preparation for, and successful completion of, internal/external audits and regulatory inspections ensuring continued certification to applicable standards and regulations.
  • Carry out the role of Management Representative on behalf of Aqtis Medical, in accordance with the requirements of ISO 13485.
  • Monitor and report on quality performance metrics, driving continuous improvement initiatives across all aspects of manufacturing and QA.
  • Develop and maintain QA documentation to support global regulatory submissions, product changes, and compliance reports, maintaining close liaison with the corporate regulatory team.
  • Facilitate training programs to ensure team compliance and awareness of regulatory and quality standards.
  • Collaborate with global regulatory teams to address queries and concerns related to audits, product submissions and registrations.
  • Ad-hoc activities to support team development and alignment with corporate regulatory and quality objectives.

Description Essential:

  • Bachelor’s degree in Life Science, Engineering, Quality Assurance, or a related field.
  • Extensive experience in Quality Assurance.
  • Knowledge of regulatory requirements for medical devices.
  • Deep knowledge of medical device regulations (ISO 13485, EU MDR, GMP).
  • Experience managing cross-functional teams in a high-stakes environment.
  • Experience working under GMP or ISO conditions in the medical device or pharmaceutical industry.
  • Certification in auditing.
  • Experience in the development, implementation, and improvement of quality management systems.
  • Fluency in English, both written and spoken.
  • Excellent analytic and problem-solving skills.
  • Strong communication and interpersonal skills to collaborate with cross-functional teams.
  • Demonstrated ability for out-of-the-box thinking.

Desirable:

  • Extensive experience in Regulatory requirements.
  • Advanced degree in a relevant discipline.
  • International experience.
  • Lean Six Sigma Certification.
  • Exceptional interpersonal and negotiation skills.
  • Training skills: experience in developing and delivering training programs for teams.
  • Experience in change management.
  • Cultural awareness.

A bit about you – do you fit this description?

  • Quality compliance: mastery in interpreting and applying FDA, ISO 13485, EU MDR and other relevant regulatory standards.
  • Strategic Planning: ability to develop strategic plans that align with corporate goals and regulatory/quality requirements.
  • Conflict resolution: skills in managing and resolving conflicts within teams or with external partners to maintain a cohesive working environment.
  • Financial acumen: understanding of budgeting, financial planning and cost management in a quality context.
  • Cultural sensitivity: awareness and understanding of diverse cultural perspectives and practices, enhancing team collaboration and global operations.
  • Technological proficiency: up-to-date with the latest software used in Quality management.
  • Reviewing expertise: exhibits proficiency in thorough reviews of quality and regulatory documentation, internal audit findings, and internal reports to assure accuracy, completeness, and compliance with all applicable standards.

We Also Offer:

  • A competitive salary
  • A 13th month
  • 25 vacation days
  • 8% holiday pay
  • Travel allowance based on €0,23 per kilometre
  • Retirement savings plan

This is an exciting opportunity to join a successful company, with big ambitions for the future.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

Please note if we receive a high volume of applications, we may close the role before the closing date noted.

By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad.

If you have any questions, please email recruitment@sinclair.com .

Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void.

We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability, and autonomy. The company is full of opportunities for those who wish to grasp it. Our people thrive on engagement, development, and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

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