Staff Software Quality Engineer, Post Market Integration
Stryker
Staff Software Quality Engineer, Post Market Integration
Job Description
Work Flexibility: Hybrid or OnsiteStryker is hiring a Staff Software Quality Engineer, Post Market Integration endoscopy and communications business. In this highly visible role, you will serve as a quality engineering leader for commercialized products, driving complex investigations, risk management activities, product quality improvements, and regulatory compliance across the product lifecycle. Partnering closely with R&D, Operations, Commercial, and Quality teams, you will lead customer complaint investigations, CAPA, change management reviews, and continuous improvement initiatives while leveraging software quality, SDLC, and quality system expertise to enhance product reliability, performance, and patient safety. This role is ideal for an experienced quality professional who thrives in a fast-paced, regulated environment and enjoys solving complex technical challenges that directly impact customers and healthcare outcomes.What you will doServe as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.What you needRequiredBachelors degree in a Science, Engineering or related disciplineMinimum of 4 years of experience in a regulated and/or technology-driven industry.Proficiency in Software Development Lifecycle (SDLC) processes and methodologies.Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including applicable health screenings, vaccinations, and background checks.PreferredExperience working within the medical device industry, including knowledge of U.S. and international medical device regulations, standards, and quality systems such as ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).Working knowledge of computer hardware and related technologies. $112,900 - $188,100 USD Annual Travel Percentage: 30%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Locations
- Texas, Flower Mound
Salary
112,900 - 188,100 USD / yearly
Skills Required
- regulated and/or technology-driven industryintermediate
- Software Development Lifecycleintermediate
- Quality Conceptsintermediate
- computer hardwareintermediate
Required Qualifications
- Bachelors degree in a Science, Engineering or related discipline (degree in a science)
- Minimum of 4 years of experience in a regulated and/or technology-driven industry. (experience, 4 years)
- Proficiency in Software Development Lifecycle (SDLC) processes and methodologies. (experience)
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). (experience)
- Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including applicable health screenings, vaccinations, and background checks. (experience)
- Bachelors degree in a Science, Engineering or related discipline (degree in a science)
- Minimum of 4 years of experience in a regulated and/or technology-driven industry. (experience, 4 years)
- Proficiency in Software Development Lifecycle (SDLC) processes and methodologies. (experience)
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). (experience)
- Ability to work within hospital and clinical environments, interact with healthcare professionals, observe live and simulated surgical procedures, and obtain/maintain all required credentials for facility access, including applicable health screenings, vaccinations, and background checks. (experience)
Preferred Qualifications
- Experience working within the medical device industry, including knowledge of U.S. and international medical device regulations, standards, and quality systems such as ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP). (experience)
- Working knowledge of computer hardware and related technologies. (experience)
- Experience working within the medical device industry, including knowledge of U.S. and international medical device regulations, standards, and quality systems such as ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP). (experience)
- Working knowledge of computer hardware and related technologies. (experience)
- $112,900 - $188,100 USD Annual (experience)
Responsibilities
- Serve as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.
- Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.
- Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.
- Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.
- Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.
- Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.
- Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.
- Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.
- Serve as a subject matter expert for quality engineering, leading complex investigations, root cause analysis, risk management activities, and system-level problem solving.
- Lead customer complaint investigations, nonconformance, CAPA, product field actions, and other regulatory quality processes, driving effective corrective actions and product improvements.
- Partner cross-functionally with customers, commercial teams, operations, R&D, and quality functions to address critical product and process quality issues.
- Review and influence change management, design, and development activities by identifying risks, challenging effectiveness, and driving continuous improvement opportunities.
- Analyze quality and operational performance metrics to identify trends, prioritize actions, and improve product quality, reliability, and compliance.
- Apply risk management, human factors, statistical methodologies, and quality engineering principles to support product development, validation, usability, and lifecycle management activities.
- Lead initiatives to improve manufacturing processes, product performance, and quality system effectiveness for commercialized products.
- Support internal and external audits, regulatory inspections, and quality system compliance activities while serving as a technical resource and mentor within the organization.
Tags & Categories
Answer 10 quick questions to check your fit for Staff Software Quality Engineer, Post Market Integration @ Stryker.
10 Questions
~2 Minutes
Instant Score