Stryker is a global leader in medical technology with a history of success and exceptional growth. We offer results-driven people a place where they can make a difference. It is our privilege to create medical technology that exceeds our customers’ expectations and improves peoples’ lives around the world.
As a Quality Process Engineer for Stryker, you will be responsible for the analysis and resolution of production issues through collaboration with engineering and material procurement teams. Perform monitoring of process data and analysis of trends, financial results and customer feedback. Exhibit a commitment to quality first culture, compliance and continuous improvement through the implementation of projects which optimize production, inspection, and quality system processes.
What You Will Do
Production Quality Management – Issue Analysis and Resolution:
Perform robust root cause analysis of production issues, implement appropriate containment, and drive corrective action.
Coordinate with Design Engineering, Regulatory, Manufacturing Engineering to conduct risk analysis of non-conformances found in manufacturing.
Coordinate with division and manufacturing engineers as well as material teams in order to drive collaboration and communication for issue resolution.
Monitor / analyze production performance trends for key quality metrics and establish appropriate control measures.
Drive detection and prevention of non-conformances to improve business results through reductions in scrap and rework costs in addition to assurance of a positive customer experience Conduct activities associated with the investigation and resolution of customer complaints.
Production Quality Management – Process Improvement:
Evaluate and improve quality inspection methods and fixtures to improve reliability and repeatability of incoming, in-process, and final QC.
Evaluate production/inspection equipment, processes, and procedures to ensure accuracy and compliance to regulatory and quality system requirements.
Drive changes to procedures as necessary.
Analyze the risk associated to non conforming inspection equipment and take action on affected product.
Operations and QC Efficiency: Facilitate resolution of MRB issues leading to reduction in number of components / products in MRB.
Optimize Stryker’s incoming, in-process, and final QC inspection plans / requirements / fixtures to efficiently detect defects in early production stages.
Ensure timely resolution of non-conformances and product ship holds. Partner with Operations and Division engineering to develop solutions to non-conformances.
Participate in validation activities / Conduct supplier audits / Work with Strategic Sourcing and Purchasing as the Supplier Quality resource.
Continuous Improvement: Identify and lead implementation of process / procedure / system improvements. For example, component qualification process, skip lot process, supplier change process, etc Lead and / or support CAPAs that can impact the Quality System and / or product quality and drive reliability improvement Provide support during internal and external audits as required.
What You Need
B.S. in engineering, or related discipline and 0+ years related experience is required.
1+ years of experience is strongly preferred.
Excellent analytical, interpersonal and organizational skills.
Effective interpersonal communications skills.
Quality Assurance knowledge and understanding.
Quality Systems knowledge and understanding (i.e. QSR, ISO 13485).
Understanding of core process methodologies and problem-solving techniques related to primary role.
Ability to understand and update engineering drawings.
Ability to generate and explain detailed proposals, guidelines, and procedures for the QA functions to departmental and/or non-departmental personnel.
Drives for results through timely decision making and the ability to prioritize, plan and measure work.
Ability to resolve conflicts and disputes by addressing multiple view points to develop a mutually satisfying outcome.
Ability to influence, motivate, and enable others to contribute to the effectiveness of the organization by using direct persuasion to convince and influence others.
Ability to interact with diverse internal customers in an effective manner.
Must be able to generate, follow and explain detailed quality requirements and inspection procedures.
Must be able to plan, organize and implement multiple concurrent tasks.
Things to Consider:
Various environmental conditions - office, production floor, warehouse, lab, customer sites (e.g. hospitals) While performing the duties of this job, it may be required to stand, walk, or sit occasionally for long periods of time. It may also be required to use hands or fingers to handle, or feel objects, reach with hands and arms, balance, stoop, kneel, or crouch May occasionally lift and/or move up to 30 pounds (seek assistance for greater amounts) Long periods of computer work The noise level is usually moderate. May be exposed to Hazardous materials. Consult MSDS in work area Exposure to used medical devices. Exposure to cleaning agents. Protective equipment is required, as indicated by area procedure. Subject to changes in procedures or work environment. May need to operate small hand tool, inspection equipment and common office equipment. Operate in a fast paced environment, sometimes requiring extended work hours.
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.