Work Flexibility: Onsite

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 opportunitiesAdvocate 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 initiativesParticipate 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 processesApply statistical methods to ensure reliability of the manufacturing processAssist 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 escapesDevelop 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 manufacturingMust 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 

Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.