Senior Quality Engineer (m/f/d) Medical Devices, Cork
Client:
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
9e6e5f2354b9
Job Views:
4
Posted:
03.07.2025
Expiry Date:
17.08.2025
Job Description:
Work Flexibility: Hybrid or Onsite
Job Summary
As a Senior Quality Engineer in our Trauma Business Unit, you will help bring innovative, life-changing medical devices to market. Working closely with cross-functional teams, you’ll ensure the highest standards of quality and safety throughout the product development lifecycle. At Stryker, you'll make a real impact on patient outcomes, grow your expertise, and be part of a global leader recognized as a Best Place to Work. This role reports to the Senior Manager, Quality Engineering and is based in Freiburg (Germany), Kiel (Germany), or Cork (Ireland).
What will you do:
1. Lead quality assurance efforts throughout the design and development phases of new products.
2. Collaborate with cross-functional teams to manage design requirements, risk assessments, and design history file documentation.
3. Responsible for leading risk management using ISO 14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
4. Support and maintain quality systems in accordance with ISO 13485, QMSR, and applicable regulatory requirements.
5. Review and approve technical documentation to ensure compliance with the company's quality system, external standards, and country-specific launch requirements, ensuring the highest level of product and process quality.
6. Drive issue resolution and support team problem-solving efforts with a focus on design quality and compliance.
7. Define design verification and validation test requirements to ensure appropriate objective evidence supports acceptance criteria, providing concise conclusions with statistical validity and graphical support.
8. Partner with development and manufacturing teams to ensure design transfer and process validation meet quality standards.
What will you need:
Required:
1. Bachelor’s degree in Mechanical Engineering or equivalent technical discipline.
2. Minimum 2 years of experience in Quality Engineering, ideally in medical devices or a similar highly regulated industry (pharma, aerospace, food & beverage). Seniority level can be adjusted based on experience.
3. Demonstrated experience in product development, design controls, and risk management.
4. Strong knowledge of ISO 13485, ISO 14971, QMSR, EU MDR, and Quality Concepts (e.g., NC/CAPA).
5. Problem-solving mindset with the ability to resolve escalated issues in cross-functional teams.
6. Fluency in English.
7. Excellent communication and stakeholder management skills.
8. Ability to advocate for product excellence and quality.
Preferred:
1. Experience with design and documentation software (e.g., CAD, PLM, SharePoint, Power BI).
2. Project management skills and ability to manage multiple tasks simultaneously.
3. Proficiency in German or French is a plus.
4. Green or Black Belt Six Sigma certification.
5. Experience working with Notified Bodies or Regulatory Authorities.
Diversity is important to us. We welcome applications from people regardless of ethnicity, nationality, gender, disability, age, or sexual identity.
Additional information
Thanks to our flexible working hours model, you will have the opportunity to work partially from home. However, a minimum of 1 day on-site at Freiburg, Kiel, or Cork is required to build relationships and maintain personal contact with colleagues and departments.
Note: The internal job title may differ from the ad title.
Travel Percentage: 10%
Please note that if you are not a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.
Bank or payment details should not be provided when applying. All applications should be made via the 'Apply now' button.
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