As a Senior / Staff CAPA Specialist (m/f/d) at Stryker in Tuttlingen, you will serve as the process owner for the NC/CAPA across the entire site. You will oversee and ensure the compliance, effectiveness, and efficiency of our NC/CAPA process, addressing quality issues with precision. Join our Tuttlingen’s quality team, working under minimal supervision, to drive excellence in CAPA processes and contribute to the development of our future state quality systems.

What will you do

• As a Senior / Staff CAPA Specialist you will be an NC/CAPA process owner across entire site in Tuttlingen.

• You will review and approve NC and CAPAs, ensuring completeness, accuracy, effectiveness, and timeliness.

• You will liaise with relevant functional groups, facilitating and mentoring teams through all stages of the NC/CAPA process.

• You will contribute to developing the optimum future state of the NC/CAPA process to meet business needs, aligned with corporate guidelines.

• You will develop and deliver training and coaching for new NC/CAPA users on NC/CAPA principles and the system.

• You will ensure users provide the necessary rigor to the eCAPA system content, maintaining a live document with all relevant evidence attached in a timely manner.

• You will act as a Problem-Solving Methodology expert, facilitating and coaching CAPA teams in applying problem-solving techniques and promoting their use and development (e.g., Human Error Reduction, 4-D).

What will you need

• You have completed BS in Engineering, Science, or related degree.

• You have gained a minimum of 2 years' experience in quality systems in the medical technology or pharmaceutical industry. Depending on years of experience and skills, the role can be adjusted to a more senior level.

• You have strong experience in NC/CAPA in medical technology or pharmaceutical industry.

• You have experience interacting with regulatory agencies such as FDA, MoH, TUV, etc., and possess thorough knowledge of US and International Medical Device Regulations.

• Ideally you have strong knowledge of supporting Quality Systems (e. g. Audits, Management review, Quality Planning).

• You possess strong computer skills, proficient problem-solving abilities, and excellent communication skills.

• Your English and German language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.

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 at least 1 day a week on site at our location in Tuttlingen should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Your application

We are looking forward to your online application including all relevant documents such as CV (in English) and diploma. Please note to upload all attachments directly in our application procedure under the item "CV".

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

Your contact:

In case you have further questions regarding the position, please feel free to directly reach out to Monika Ambroziak: monika.ambroziak@stryker.com