Lead the Design Quality team, which includes the responsibilities for Advanced Quality Engineering (AQE), Risk Management, Design Assurance Labs and Compliance Engineering. This team will focus on Quality in support of New Product Development (NPD) and will serve as a single point of contact to the NPD design teams. This role engages strategically across the business to ensure that customer satisfaction and patient safety are met for the products designed and manufactured from the Stryker Redmond facility. Direct reports include a highly technical team based in the Stryker Medical Redmond facility.
* Define, lead and implement strategic approaches to quality and compliance engineering for the design and development of products.
* Works collaboratively to deliver novel solutions for customers through partnering with engineering, marketing and compliance to support strategic product roadmaps.
* Leads risk management throughout the enterprise, ensuring tools are deployed holistically throughout the product lifecycle.
* Leads the execution of design verification testing for the entire product lifecycle, ensuring that project schedules are met and projects fully resourced and executed.
* Ensures compliance to industry and device standards for products, systems and laboratories.
* Drives a process-focused mentality through the organization to ensure that patient safety and compliance are maintained while efficiencies are gained. Develops strategies for next-generation thinking and executing in the area of design quality.
* Provide expertise and guidance in interpreting and applying industry and design standards, governmental regulations, agency guidelines and internal policies to ensure compliance and safety.
* Serve as SME representing the Company by hosting audits with various governmental agencies, such as FDA, CSA/UL and ISO 3rd party auditors, to provide information related to quality documentation, CAPA, process controls, design quality, and design or process changes.
* Directly influence the development of customer-focused quality, quality systems improvements, and business process improvement initiatives.
* Represent the Physio-Control organization in a leadership capacity to other functions.
* Observe and evaluate industry trends and benchmark quality and development/design control operations against industry standards. Make recommendations and implement proactive improvements as needed.
* Provide coaching, development, and performance management to direct reports and their respective staff.
* Perform other related duties as assigned by management.
* B.S. degree in engineering, quality management or related scientific discipline.
* Minimum 10 years work experience in medical device or similarly regulated industry, with a minimum of 7 years management experience.
* MS or MBA preferred.
* Strong working knowledge of FDA QSR, GMPs, ISO, MDD and other Quality System regulations.
* Strong leadership, interpersonal and communication skills (both written and verbal).
* Ability to handle a variety of projects and coordinate the efforts of direct reports at the same time.
* Ability to function in a team environment.
* Ability to work with outside suppliers, medical and technical professionals
* Strong project management skills
* Strong leadership and decision making skills.
* Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse
* Sitting/Standing 8+ hours per day
* Ability to travel up to 15% of the time
Work From Home: No
Travel Percentage: None
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.