Principal Quality Engineer (CAPA)

The Principal Quality Engineer (CAPA) is responsible for leading the Inari Division CAPA program to ensure corrective and preventive actions are addressed in conformity with applicable global regulatory requirements and standards. Candidates must be within commutable distance of Irvine, CA.

What you will do

As the Inari Divisional Process Owner (DPO) of the CAPA subsystem, this role is responsible formanaging and maintaining open CAPAs in the electronic TrackWise system.

Providing expertise, training, and guidance in performing root cause analysis using appropriate investigation techniques.

Conducting risk assessments to determine the impact of systemic non-conformities on QMS, product, and / or process.

Developing detailed corrective and preventive action plans to address root cause(s) of existing and potential nonconformities.

Leading efforts with cross-functional partners to execute action plan(s), ensuring that corrective and preventive actions do not adversely affect the finished product, patient safety, or regulatory compliance.

Determiningmethodology for evaluating the effectiveness of corrective or preventive actions using appropriate statistical techniques.

Performing data trending and analysis of CAPA metrics and presenting findings to cross-functional leadership.

Ensuring that all activities are performed and documented per company policies and procedures intended to assure product safety and effectiveness.

Initiating, leading, and executing quality system improvement projects with substantial impact.

Demonstrating appropriate risk-based decision making and prioritizing key activities to maintain product conformity and QMS compliance.

Supporting internal and external QMS audits as Subject Matter Expert for corrective and prevent actions within the product lifecycle and QMS.

What you need

Bachelor's degree in engineering discipline required.

Minimum of 8 years of related work experience with a strong understanding of corrective and preventive actions.

Experience in medicaldevices or related industries.

Strong knowledge of CAPA as it relates to Quality Management Systems, internal and external audits, product design controls, and risk management.

Preferred

Ability to manage competing priorities in a fast-paced and dynamic environment.

Strong problem-solving, organizational, analytical, and critical thinking skills.

Excellent, proven interpersonal, verbal, and written communication skills.

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.

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.