"Alerted.org

Product Acceptance Engineer - Remote

Stryker is hiring a Product Acceptance Engineer to act as the primary liaison between Quality Assurance and Operations within the Finished Goods Operations team. In this role, you will provide expert QA and scientific support to help achieve operational goals. You will also be responsible for ensuring sterility compliance of medical devices in accordance with regulatory standards, leading the testing, monitoring, and validation of cleaning and sterilization processes and related utilities.

What you will do:

+ Lead and improve lot review and release processes within Finished Goods Operations.

+ Drive continuous improvement initiatives across inspection and acceptance activities, expanding beyond Finished Goods.

+ Provide quality expertise and support across functions, including NC/CAPA ownership and resolution.

+ Ensure compliance with sterility standards through oversight of environmental monitoring, utilities, and sterilization processes (EtO, radiation).

+ Review and validate cleaning and sterilization protocols in line with ISO standards.

+ Analyze sampling and monitoring data using statistical techniques to identify trends and trigger actions.

+ Act as microbiology technical lead in cross-functional teams, supporting product and process issues.

+ Support external audits (FDA, IMB, BSI) and contribute to procedure development and training.

What you need:

Basic Qualifications:

+ Bachelor’s degree in Science, Engineering, or a related field

+ 0+ years of experience

Preferred Qualifications:

+ Experience in working in a compliance risk situation.

+ Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise

+ Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)

+ Previous experience with ERP systems (SAP, Oracle etc,)

$69,100.00 - $139,600.00 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.

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.