Quality specialist Jobs in Schwentinental

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 consistently recognized as a Best Place to Work. This role reports to the Senior Manager, Quality Engineering and is based in Freiburg (Germany) or Kiel (Germany) or Cork (Ireland).

What will you do :

Lead quality assurance efforts throughout the design and development phases of new products.

Collaborate with cross-functional teams to manage design requirements, risk assessments, and design history file documentation.

Responsible and leading risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk / benefit justifications to executive leadership.

Support and maintain quality systems in accordance with ISO 13485, QMSR and applicable regulatory requirements.

Review and approve technical documentation to ensure compliance with the company's quality system, external standards and country specific launch requirements and to ensure the highest level of product and process quality.

Drive issue resolution and support team problem-solving efforts with a focus on design quality and compliance.

Drive the definition of design verification and validation test requirements that will ensure appropriate objective evidence will be available to support acceptance criteria are met by providing concise conclusions with statistical validity and graphical support

Partner with development and manufacturing teams to ensure design transfer and process validation meet quality standards.

What will you need : Required :

Bachelor’s degree in Mechanical Engineering or equivalent technical discipline.

Minimum 2 years of experience in Quality Engineering, ideally in medical device or a similar field within a highly regulated industry (pharma, aerospace, food & beverage). Seniority level can be adjusted based on experience.

Demonstrated experience in product development, design controls, and risk management .

Strong knowledge of ISO 13485, ISO 14971, QMSR, EU MDR and Quality Concepts (e.g. NC / CAPA).

Problem-solving mindset with ability to resolve escalated issues in cross-functional teams.

Fluency in English.

Excellent communication and stakeholder management skills.

Demonstrated ability to advocate for product excellence and quality.

Preferred :

Experience with design and documentation software (e.g. CAD, PLM, SharePoint, Power BI).

Project management skills as well as have the ability to manage multiple tasks simultaneously.

Proficiency in German or French is a nice to have.

Green or Black Belt Six Sigma certification.

Experience working with Notified Bodies or Regulatory Authorities.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.

Additional information

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of minimum 1 day on site at our location in Freiburg OR Kiel OR Cork should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Please note that the internal job title may differ from the ad title.

Travel Percentage : 10%