Quality Engineer

Location: Belfast, United Kingdom

Time Type: Full time

Job Description

Work Flexibility: Onsite

6 month fixed term contract - onsite

Position Summary:

The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control and preventive activities to ensure compliance with regulations and standards.

Collaborate with cross-functional teams, assist in resolving quality issues, and contribute to continuous improvement initiatives within manufacturing and quality processes.

Essential Duties & Responsibilities:

•Work closely with Operations and Business Functions to ensure quality performance of products and processes

•Collaborate cross-functionally with internal and external teams to resolve quality issues

•Own and manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure

•Support or own Corrective and Preventive Actions (CAPAs) through root cause analysis to closure

•Disposition of non-conforming product through MRB, issuing NCs as appropriate

•Communicate with suppliers regarding NCs and escalate Supplier Corrective Action Requests (SCARs) as needed

•Participate in the development and continuous improvement of internal manufacturing processes for existing products

•Review and support Change Management activities (both supplier and internal)

•Create and/or review new or revised procedures

•Maintain and analyse KPIs to monitor product and process quality; identify trends and implement corrective actions

•Support the execution and analysis of manufacturing complaints and product field actions

•Apply statistical methods for process analysis and control

•Provide QA support during internal and external audits

•Support process/equipment validation, qualification, and Measurement System Analysis (MSA)

•Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes

•Assist in manufacturing/product transfers between plants/facilities, performing appropriate quality activities

•Execute and analyse Quality Acceptance Tests (QATs)

•Support with product holds and executing containment Plans

•Support in risk management practices and tools,use knowledge in process risk. Support and provide input for risk management by identifying opportunities and weaknesses.

•Support and implement Lean principles through standardisation and waste elimination

•Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.

•Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external

Education & Special Trainings:

Honours Bachelor’s Science/Engineering Degree

Qualifications & Experience:

•0–2 years’ experience in a Quality or Regulatory Affairs role; prior industry experiences desirable

•Familiar with ISO 13485, GDP, and GMP concepts

•Solid understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics

•Proficient in Microsoft Word, Excel, and PowerPoint

•Strong problem-solving, analytical, and communication skills with high attention to detail

•Builds strong relationships through open communication, respect, and trust

•Team player with a customer/stakeholder-focused approach

•Diplomatic, tactful, and effective at leveraging interpersonal skills

•Embraces change with a continuous improvement mindset.

•Excellent written and spoken English

•Confident representing Quality in cross-functional settings

•Self-starter able to manage multiple tasks in a fast-paced environment

•Willing to work as part of a multi-site team; some travel required

•Knowledge of risk-based thinking and statistical concepts is a plus

 

United Kingdom Pay Ranges:

• United Kingdom: £31,800 - £52,900 GBP Annual

 

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

 

If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

 

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