Sr Engineer, Quality Assurance Engineering
Role summary
The Sr Engineer, Quality Assurance Engineering role focuses on enhancing quality performance and ensuring compliance within a regulated environment, specifically medical devices. The position involves providing validation engineering support, leading quality initiatives for continuous improvement and risk reduction, and overseeing critical quality processes such as Non-Conformances (NCs) and CAPAs. Key responsibilities include reviewing and approving change management activities, acting as a subject matter expert for validation, and supporting quality acceptance tests. The role also requires participation in risk management activities and interfacing with auditors and regulatory bodies. A Bachelor's degree in engineering and a minimum of 2 years of experience in a quality, engineering, or validation role within a regulated environment are required.
Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
What You Will Do
- Provide quality and validation engineering support to ensure compliance with applicable regulations, standards, and internal procedures.
- Lead and advocate for quality initiatives focused on preventative measures, continuous improvement, and risk reduction across products and processes.
- Oversee, review, and approve Non‑Conformances (NCs), CAPAs, and root‑cause investigations, mentoring teams in structured problem‑solving methodologies.
- Support and approve change management activities, ensuring effective risk evaluation and regulatory compliance.
- Provide subject‑matter expertise for process, equipment, and computer system validation/qualification, including review and approval of validation documentation.
- Actively participate in the development and improvement of manufacturing processes for existing and new products.
- Support execution, analysis, and review of Quality Acceptance Tests (QATs) and First Article Inspections.
- Lead and contribute to risk management activities, applying tools such as FMEAs, FTAs, and other risk‑based techniques.
- Serve as site owner for at least one validation specialty, acting as the primary technical resource and validation contact.
- Interface with internal and external auditors and regulatory bodies, providing clear and effective technical narratives within your area of expertise.
- Collaborate cross‑functionally to ensure quality and validation considerations are effectively integrated into operational and project decisions.
What You Need
- Bachelor’s degree in engineering
- Minimum 2 years of experience in quality, engineering, validation, or a heavily regulated environment.
Preferred
- Engineering degree in Mechanical, Electrical, Chemical, or Biomedical Engineering.
- 2+ years of experience in quality, engineering, validation, or regulated manufacturing environments.
- Experience supporting R&D, New Product Development (NPD), New Product Introduction (NPI), or Commercial Operations activities.
- Familiarity with ISO 13485, GMP, GDP, and medical device manufacturing processes.
- $89,400.00 - 148,900.00 USD Annual salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
