Work Flexibility: Onsite

Stryker is hiring a Senior Staff Quality Systems Engineer for our Quality Management Systems (QMS) team to support and manage Supplier Quality activities within our Neurovascular division who will be responsible for ensuring an effective and efficient quality management system is built and maintained.

What you will do:

Lead in developing optimum future state of the QMS processes for business needs, aligned with CorporateDevelop & deliver training and coaching for new QMS users on QMS principles and on the applicable systemsLead auditor capable of ensuring compliance with the appropriate internal & external regulatory requirements, (including but not limited to Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)Co-ordinates external consultants to perform supplier auditsUnderstands Quality Systems & web-based interactions.Key contributions to the business process(es) and understands how IT systems support those business processes.

What you need:

Required:

Bachelor’s degreeMinimum of 6 years in Quality or Regulatory Affairs environment with 3 years’ experience within the area of Quality Management Systems.Experience in Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning)Experience working as a Supplier Quality Engineer in a Medical Device regulated environment required.  Experience in interacting with regulatory agencies (FDA, BSi, etc.).

Preferred:

Bachelor’s degree in science or engineeringLead Auditor Certified and/or Lean Six Sigma Qualification

Travel Percentage: 30%

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.