Sr Engineer, Quality Assurance Engineering

Stryker•Irvine, CA

7d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering
Minimum 2 years of experience in quality, engineering, validation, or a heavily regulated environment.

Nice To Haves

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.

Responsibilities

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.