Okay, I've searched for Software Quality Engineer roles specializing in post-market activities, hybrid positions located in San Jose, CA, in the medical device industry, requiring a Bachelor's degree and at least 3 years of experience. I have found 47 positions for you.

Sure. Here's the analysis:

Job Analysis:

The Software Quality Engineer, Post Market role at Stryker is fundamentally centered on ensuring the ongoing safety, effectiveness, and compliance of medical device software solutions after they have been released to the market. This position is critical in bridging technical quality assurance with regulatory and customer-facing activities, supporting Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products. The role requires coordination across multiple internal teams—including Professional Services, Technical Support, R&D, Legal, and Compliance—and external stakeholders such as customers, to manage post-market quality issues like non-conformances, complaints, and corrective/preventive actions (NC/CAPA). The candidate must be adept at applying and interpreting regulatory frameworks such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304 within a fast-evolving software environment. Success in this role means maintaining high customer satisfaction by proactively resolving software-related quality issues, executing risk assessments, and driving continuous process improvements from a data-informed perspective. The hybrid work model and use of multiple enterprise tools (Salesforce, SAP, Jira, TrackWise, etc.) underscore the complexity and scale of operational collaboration. Candidates will need strong analytical skills, regulatory knowledge, and the ability to operate autonomously while influencing cross-functional teams under tight compliance standards.

Company Analysis:

Stryker is a well-established global leader in medical technologies with a focus on improving patient outcomes through innovation in MedSurg, Neurotechnology, Orthopaedics, and Spine. This role sits within the Digital Health division, highlighting the company’s investment in software-driven medical solutions and their regulatory assurance post-launch. The company’s market leadership and scale suggest a structured, compliance-focused environment where quality and risk management are paramount. The dispersed locations and hybrid schedule reflect a balance of flexibility and in-person collaboration, likely fostering a culture that values teamwork alongside individual accountability. Stryker’s robust benefits and equal opportunity stance point to an inclusive and employee-focused culture. For a candidate, this means the role offers exposure to cutting-edge medical software quality challenges within a mature yet innovative organization that values technical rigor, continuous improvement, and cross-functional partnership. Strategically, this hire supports Stryker’s goal of sustaining product excellence and regulatory compliance amidst rapid digital transformation, making it a pivotal role that impacts customer safety and brand reputation globally.

Absolutely. Here are some mock interview questions that could come up:

• Behavioral: Tell me about a time when you had to lead a cross-functional investigation for a quality complaint. How did you manage the stakeholders and ensure resolution?
• Behavioral: Describe an instance where you identified a process improvement opportunity in a post-market environment. What approach did you take to implement your recommendation?
• Behavioral: How have you handled scenarios where you faced ambiguity regarding regulatory requirements or customer expectations? Give a specific example.
• Behavioral: Can you share an experience working with software support teams to resolve technical issues that impacted product quality or compliance?
• Technical: How would you approach conducting a Health Hazard Analysis for a new software release in a SaMD product?
• Technical: Explain your familiarity with FDA 21 CFR Part 820 and ISO 13485 in the context of software quality assurance. How have you applied these standards in your past work?
• Technical: What strategies do you use to effectively manage NC/CAPA processes within enterprise software tools such as TrackWise or Jira?
• Technical: Discuss your experience with cybersecurity monitoring and data privacy in medical device software. How do you collaborate with Legal or Compliance teams to address related concerns?
• Situational: Imagine you receive a critical customer complaint about software behavior that might affect patient safety. What are your initial steps in investigating and resolving this?
• Situational: You find discrepancies in KPI data reporting during a quarterly business review. How would you address and communicate this issue to leadership and the business?
• Situational: Suppose a new regulation is introduced that impacts post-market software quality processes. How would you adapt existing procedures and ensure the team complies?
• Company Fit: What excites you about working for Stryker’s Digital Health division specifically, and how do you see yourself contributing to our mission?
• Company Fit: How do your past experiences with leading tech companies or healthcare IT prepare you for the challenges faced at Stryker?
• Company Fit: In what ways do you align with Stryker’s culture of innovation, quality, and patient-focused outcomes?
• Questions for Interviewer: How does Stryker’s Digital Health division balance innovation with stringent regulatory compliance in post-market activities?
• Questions for Interviewer: Can you describe the typical career progression for someone in this role? What growth opportunities exist within the quality organization at Stryker?
• Questions for Interviewer: How does the cross-functional collaboration work between Post Market Quality, R&D, and Technical Support teams on a daily basis?