Quality Assurance Officer
Sinclair is Hiring! Join Our Team as a Quality Assurance Officer ๐
We are currently recruiting for Quality Assurance Officer] at Almere, Netherlands. The Quality Assurance Officer will be responsible for supporting and maintaining the Quality Management System to ensure compliance with regulatory requirements and internal quality standards within the medical device industry. This role ensures products are manufactured, documented, and released in accordance with applicable regulations, including ISO 13485, MDD and MDR. The Quality Assurance Officer will contribute to quality assurance activities such as document control, CAPA management, internal audits, non-conformance investigations, and continuous improvement initiatives. The position plays a critical role in maintaining product safety, regulatory compliance, and overall quality performance across the organization.
The ideal candidate will have:
๐นMinimum 2 years of experience in a quality role within the medical device industry.
๐นFluent in English. Excellent written and verbal communication skills.
๐นStrong documentation and organizational skills.
๐นExcellent analytical and problem-solving abilities.
๐นFamiliarity with CAPA systems, non-conformance handling, and root cause analysis tools (e.g., 5 Whys, Fishbone).
๐นProficiency in Microsoft Office and quality management software.
Hours of work: 40
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, 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.
Sinclair Values:
โ
Act with Integrity Consistently doing the right thing even when itโs the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines
โ
Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact
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Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
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One Company, One Goal Working towards unified mission, we are all Sinclair and be seen by customers as one company in every way
โ Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues
What You'll Be Doing:
[List the key responsibilities from the job description]
๐นMaintain and support the companyโs Quality Management System in compliance with ISO 13485 and applicable regulatory requirements.
๐นAssist in internal and external audits, including notified body and regulatory inspections.
๐นManage document control processes including SOPs, work instructions, and records.
๐นSupport CAPA processes including investigation, root cause analysis, and effectiveness checks.
๐นCreate review and approve DMR activities.
๐นMonitor and report quality metrics and KPIs.
๐นSupport complaint handling and non-conformance investigations.
๐นProvide quality training to staff as needed.
๐นChange management: ownership of local and global change
Your skills and experience
Essential:
๐นAttention to detail
๐นRegulatory compliance knowledge
๐นStrong communication skills
๐นTeam collaboration
๐นTime management
๐นContinuous improvement mindset
๐นAbility to work independently with minimal supervision.
๐นMust be self-motivated
Desirable:
๐นBachelorโs degree in Engineering, Life Sciences, or a related field.
๐นExperience with EU MDR requirements.
๐นUnderstanding of risk management principles in accordance with ISO 14971
What We're Looking For:
๐นA great team member
Perks & Benefits:
๐ฐ Competitive Salary & Performance Bonuses
๐ Career Growth & Learning Opportunities
๐ Fun Team Events & Supportive Culture
๐นPension paid by employer
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 opportunity 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.
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.
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.
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
- Division
- Operations
- Department
- QUALITY
- Role
- QA Specialist
- Locations
- Sinclair, The Netherlands