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Stryker is hiring Senior Quality Assurance Engineer in Portage, Michigan , to support our Instruments Division.

In this role, you will collaborate with various internal stakeholders to improve product quality, identify continuous improvement opportunities, and provide technical/compliance support. This is an Onsite position in Portage, MI, candidates must be in a commutable distance.

What you will do:

• Build relationships with various divisions/business units the manufacturing facility builds product for.

• Drive continuous improvement opportunities in the Quality Assurance area, including cost reduction opportunities

• Advocate for and lead the execution of initiatives & projects to enhance quality performance and manufacturing improvements to ensure compliance to regulation and standards.

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Provide oversight and approval of NC & CAPA, mentor in problem solving and root causing activities.

• Work collaboratively with operations & strategic partners, such as Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives

• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.

• Ensure regulatory requirements are incorporated into projects and processes

• Apply statistical methods to ensure reliability of the manufacturing process

• Assist in the development, responsible for review & approval of process and equipment validation/qualification.

• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes

• Develop and provide input for risk management by identifying opportunities and weaknesses.

• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling

What you need:

• Bachelor of Engineering - Biomedical, Mechanical or related field required.

• 4+ years of experience is required.

• Strong foundation in quality systems and manufacturing

• Must have a good understanding of engineering and quality concepts/theories.

Preferred:

• Familiarity in ISO 13485, GDP and GMP concept

• Experience in a highly regulatory environment desirable.

• Knowledge of PFMEA, GD&T, validation programs and SPC processes.

• Understanding of manufacturing prints and tolerancing.

• Ability to influence and work cross-functionally

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.