Senior Design & Customer Quality Engineering Manager - OR and Video Integration en Flower Mound, TX a Stryker Corporation

Fecha de publicación: 9/28/2020

Resumen de la oferta

Descripción del empleo

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.

Stryker is hiring a Senior Design & Customer Quality Engineering Manager - OR and Video Integration in Flower Mound, TX.

Who we want:

Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

What you will do:

As a Senior Design & Customer Quality Engineering Manager, you will implement quality standards, ensure and execute compliance on every stage of the process. Develop and implements quality assurance strategies and regulations. Assess potential risks, ensures compliance and gives recommendations. Takes responsibility for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards. Coordinates quality training.


  • Managing Quality Engineers responsible for fixing product performance and quality issues experienced in the field
  • Working with customers and field teams to maintain product quality and support their needs (including sustainment quality engineering and reliability engineering like responsibilities)
  • Responsible for new product development design quality and aspects of design assurance
  • Responsible for working with users, surgeons to carry out product labs for quality and performance feedback and design validation etc.
  • Responsible for product safety and cybersecurity risk management
  • Manage day-to-day quality processes to ensure issues are appropriately evaluated.
  • Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
  • Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
  • Serve as Subject Matter Expert for quality processes.
  • Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
  • Establish standard process to ensure appropriate resolution and management of the responsible task owner.
  • Chair meetings required to drive closure of quality issues.
  • Manage and provide updates for quality metrics. Implement appropriate enhancements.
  • Represent quality processes during internal and external audits.
  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
  • Recruit, select, and on-board top talent.
  • Develop talent within team to increase performance. Actively address performance issues on team.
  • Maintain a high level of team engagement.
  • Maintains and manages cost center for multiple business units
  • Responsible for improvement of metrics/KPIs f for multiple subordinate quality teams
  • Participates and provides support during FDA audits
  • Leverages relationships with cross functional managers within business units to set key goals.
  • Involved in key projects across multiple units.
  • Conducts periodic review of the Quality Program with senior leadership within the division
  • Supports new product design and development teams to launch new products with high quality that meet user needs.
  • Directs and coordinates activities and operations of advanced quality engineering. Providing the leadership, mission and vision for Quality organization.
  • Developing, implementing and maintaining procedures focused on methods and processes involved in the manufacturing of products.  Additionally, responsible for ensuring the quality and compliance of all products to Regulatory Standards within FDA and international guidelines.
  • Designs, develops, and implements comprehensive quality engineering programs.
  • Maintains, enforces, and measures quality assurance processes
  • Responsible for ensuring, tracking and reporting quality and reliability for released products.
  • Responsible for reviewing engineering changes to products via internal change control system for product changes.
  • Responsible for overseeing complaint handling, MDR-MDV reporting and product field action decisions.
  • Coordinates with other managers and associates to identify critical success factors, develop    measurement systems, and implement continuous process improvement methodologies.
  • Reviews and evaluates processes and services to correct Quality System and product deficiencies and to subsequently formulate improvements.
  • Works to ensure product quality, performance, and conformity with applicable regulations and company established procedures.
  • Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.
  • Hires, trains, supervises, motivates, and develops Quality Assurance staff; manages schedules and workflow.
  • Maintains the Quality System and its subparts as related to product realization.
  • Serves as topical expert in applicable domestic and international regulations and standards e.g., QSR, 13485.
  • Assigns duties and monitors quality of work; assures staff conforms to government regulations and organizational policies and procedures.
  • Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
  • Will be involved with outside Inspection of the Quality System: FDA and Notified Body auditors
  • Keeps up to date on overall activities of team, identifying problem areas and taking corrective actions.
  • Develops and conducts staff training, conducts performance/merit reviews.
  • Coordinates priorities with associated business and functional managers.
  • Performs other duties as assigned by manager.

What you need:

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 10+ years’ experience working in engineering, quality, new product development, manufacturing or regulatory
  • Minimum 3+ years management experience

Preferred Qualifications:

  • Bachelor’s Degree in Engineering strongly preferred
  • Software or electrical engineering background or similar with related experience
  • Experience working with software, electrical products – preferably at a system/integration level highly desired
  • Strong leadership, influencing, and negotiation skills
  • Prefer 4-5+ years of people management experience
  • The ability to manage complexity in a cross-functional matrix environment
  • Excellent written and oral communications and interpersonal relationship skills
  • Proven abilities to successfully interact with R&D and QA leadership

Work From Home: Occasional

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.

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