Quality Engineer in Leesburg, VA at Stryker Corporation

Date Posted: 10/5/2020

Job Snapshot

Job Description

Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Quality Engineer, you will support the following:

  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Collaborates with Divisional, cross-functional and supplier’s teams to address top quality issues.
  • Approval of quality records.
  • Participates in creation and/or review of new or modified procedures. 
  • Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
  • Applies statistical methods of analysis and process control to current operations in support of management review, CAPA and other quality system processes.
  • Serves as the GQO Quality representative on product development teams.
  • Critical assessment of internal and supplier proposed change management activities.
  • Develops understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
  • Contributes to internal and supplier driven non-conformances and manage the timely closure of NC's.
  • Communicates with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
  • Supports CAPA projects and manage to timely root cause investigation, implementation and closure. 
  • Supporting as subject matter expert for internal and external audits by regulatory agencies, notified bodies, competent authorities, etc.
  • Leads quality system projects of a small scope and complexity.
  • Dispositions non-conforming product within the material review board (MRB), issuing NC's as appropriate.
  • Maintains KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • Collaborates with appropriate stakeholders to identify and execute opportunities for supplier part certification as required.
  • Support the creation and maintenance of inspection methods and sampling
  • Supports purchasing control activities including on-site audits, desktop audits, and supplier file creation/update.
  • Supports the development and improvement of the manufacturing processes for existing products.
  • Supports PPAP activities for supplier changes.
  • Assists with execution and analysis of manufacturing related complaints and product field actions.
  • Supports the development and review of process and equipment validation/qualification.
  • Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. 
  • Supports manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
  • Develops preventive maintenance programs for production equipment.
  • Supports equipment, process, MSA and software validation protocols and reports.
  • Supports product recall activities.
  • Collaborates with Regulatory to execute the creation and revisions of Instructions for Use (IFUs).

What you need

Basic Qualifications:

  • Bachelor’s Degree is required.

Preferred Qualifications:

  • Bachelor’s Degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended.
  • Experience working in a quality role for a medical device company is strongly preferred.
  • Experience working in cross-functional teams.
  • Ability to read and interpret engineering drawings and other technical specifications preferred
  • Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Work From Home: Occasional

Travel Percentage: 10%

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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