Stryker Sr. Manager, Quality Assurance in Flower Mound, Texas
Direct and monitor quality programs and systems for the assigned Operations site(s) to ensure Stryker products consistently meet or exceed expectations, and that all quality related regulatory requirements are met. Partner with leadership from Global Quality and Operations and Stryker Divisions to develop strategies for improving quality, cost and service for new and existing products and processes.
Direct the development and implementation of quality activities for assigned Operations site(s) to ensure:
Products and processes consistently conform to Stryker, FDA, ISO and other quality related regulatory requirements, including systems for Purchasing Controls, Identification and Traceability, Production and Process Controls and Changes, Nonconforming product and CAPA, Acceptance Activities (Inspection and Test Service).
Ensure harmonization and standardization of quality systems, metrics and processes across the sites as feasible.
Effective management and/or support to audits from quality related regulatory agencies and notified bodies at assigned Operations site(s), in partnership with Division RAQA heads and Operations leadership.
Product identification and traceability is maintained through various stages of the manufacturing and distribution process.
Processes are in place to address product handling and storage, reprocessing, rework and product release consistently across manufacturing sites.
Processes are in place to provide for appropriate and consistent product and/or related investigations and CAPA at assigned operations site(s).
Adequate inspection and tests are being carried out and containment activities immediately as required.
Effective and timely communication with Division RAQA leaders of any potential field actions and product holds being investigated,
Successful execution of quality-related supplier management activities, including audit, CAPA and change management.
Successful execution of quality engineering-related activities, including problem solving, product and process quality improvement.
Successful execution of quality control-related functions, including acceptance activities, product testing, product disposition.
Development and monitoring of budgets for the assigned Quality function, including ensuring appropriate resources to meet/exceed plant quality goals and Global Operation and Divisions’ objectives.
Hire, coach, develop, and mentor Quality staff to ensure their ongoing career development and personal effectiveness.
Perform Staffing reviews of subordinates and oversees the staffing of the Quality teams at the Campus.
Allocate/re-allocate internal and external resources as needed to ensure the appropriate Quality organizational structures are in place to operate a compliant operations business unit.
Initiate training programs to advance understanding of regulatory requirements and quality concepts.
Partner with Operations and Division leaders to ensure:
A culture of partnership, transparency, service and collaboration exists between Global Quality, Divisions and Operations.
Promoting and strengthening the Culture of Quality First throughout the organization.
New products are successfully transferred to manufacturing sites and suppliers, resulting in a timely launch of high quality products.
Effective monitoring of key quality data for assigned plants and suppliers, including product quality trends and reporting.
Leadership in planning and execution of operations internal Quality compliance audits and CAPAs.
Support of Global Quality and Operations Due Diligence, Acquisition and integration activities as required.
Strategic plans and quality objectives are developed that support Global Quality and Operations. Evaluation of site performance against those goals and priorities. Executive leadership of management review responsibilities.
Collaborate and support of companywide quality planning continuous improvement projects.
Excellent analytical skills
Excellent interpersonal skills
Demonstrated effective managerial skills
Excellent organizational skills
Quality Assurance knowledge and understanding
Quality Systems knowledge (QSR, ISO 13485)
Certifications in quality field such as Six sigma, CQM, CQE, etc
Possesses strong understanding of core process methodologies and problem-solving techniques related to primary role.
Possesses ability to generate and explain detailed proposals, guidelines, and procedures for the QA functions to departmental and/or non-departmental personnel.
Possesses strong understanding of financial information and metrics as they relate to the company and industry.
Drives for results through timely decision making and the ability to prioritize, plan and measure work.
Uses direct persuasion to convince and influence others.
Resolves conflicts and disputes by addressing multiple view points to develop a mutually satisfying outcome.
Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization.
Demonstrates success working with others, learning from others, and building consensus to achieve established goals.
Possesses the ability to interact with diverse internal and external customers in an effective manner.
Communicates information verbally and in writing in the appropriate language and format according to the audience.
EDUCATION and experience:
B.A. or B.S. in engineering, engineering management, or related discipline
5-10 years as a Manager of a QA/RA or other technical function or applicable technical, customer and product experience
Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Generally involves sitting most of the time.
Must be able to communicate with large groups of people.
Must be able to review printed materials.
Insert detailed job description here.
Work From Home: No
Travel Percentage: Up to 25%
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com