Senior Quality Engineer, New Product Development (Hybrid)

The Senior Quality Engineer, New Product Development at Stryker plays a pivotal role in ensuring product and process quality for medical devices and formulated products. Responsibilities include leading risk management activities, engaging in design reviews, developing quality assurance documentation, supporting regulatory submissions, and maintaining compliance with internal quality systems. This role also requires analyzing critical quality attributes, evaluating predicate products, and supporting design transfers to ensure successful product launches.

To qualify for the Senior Quality Engineer, New Product Development position at Stryker, candidates need a Bachelor's degree in science, engineering, or a related field, along with a minimum of 3 years of experience in medical device or pharmaceutical manufacturing. Proficiency in FDA regulations and ISO standards is crucial, alongside strong project management skills and an understanding of quality concepts like CAPA and statistical analysis.

As a Senior Quality Engineer at Stryker, interaction with regulatory agencies is a critical component of the role. This involves assisting with regulatory submissions, conducting reviews to ensure compliance with FDA, MoH, and TUV standards, and supporting the creation of documentation required for audits and inspections. Successful engineers must possess the ability to communicate effectively with these agencies and navigate complex regulations.

Candidates for the Senior Quality Engineer position at Stryker are preferred to have proficiency in Advanced Quality tools such as FMEA, GD&T, and Root Cause Analysis. Experience with statistical analysis programs like MiniTab is also beneficial. Familiarity with Six Sigma methodologies, particularly Green or Black Belt certification, can enhance an applicant's profile, showing a commitment to quality improvement and process optimization.

The travel requirement for the Senior Quality Engineer, New Product Development position at Stryker is approximately 20%. This travel may involve visits to manufacturing sites, external partners, or other business locations to ensure alignment of quality standards and assist in product design transfers, enhancing the role's engagement with diverse teams and projects.

In your answer, provide specific examples of past projects where you led risk management activities, detailing the methodologies you used, such as developing risk management files and conducting risk reviews. Highlight your ability to identify risks and how you ensured their mitigation during design and manufacturing processes.

Share your familiarity with FDA CFR regulations and ISO standards relevant to medical devices. Discuss your experience in implementing quality management systems to align with these regulations and provide examples of how you've maintained compliance during audits or regulatory submissions.

Discuss specific types of quality assurance documentation you've created, such as verification and validation reports. Emphasize how these documents supported regulatory submissions and enhanced product quality by providing objective evidence for acceptance criteria.

Explain your proficiency with statistical tools like MiniTab. Describe the types of analyses you've performed to determine product acceptance limits and establish process parameters, and how these analyses assisted in resolving quality issues effectively.

Share an anecdote that showcases your project management skills. Detail how you prioritized tasks, coordinated with various teams, and ensured that all projects remained on track while maintaining high quality standards.

Talk about specific testing methodologies you've utilized to optimize efficiency while ensuring compliance. Provide examples of how you’ve streamlined testing processes, whether through adopting new tools or techniques.

Discuss your methodology for conducting design reviews thoroughly, including how you identify potential risks and track their mitigation throughout the development cycle. Illustrate this with examples of successful risk management that enhanced product outcomes.

Explain how you work alongside production teams to ensure quality standards are met during product design transfers. Share examples of how effective collaboration led to successful product launches or resolved issues in the production process.

Highlight your experience with quality concepts such as Corrective and Preventive Actions (CAPA) and your involvement in audit processes. Provide an example of how you implemented a CAPA process that solved a significant quality issue.

Provide a brief overview of specific challenges you've encountered in your previous roles, focusing on regulatory hurdles or production-related issues. Discuss the strategic approaches and problem-solving techniques you deployed to successfully navigate these challenges.