Staff Internal Quality Auditor
Staff Internal Quality Auditor
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 77200 - 123700
1 Vacancy
Job Description
Stryker is currently seeking a Staff Internal Quality Auditor to join our global Quality Management Systems team. This is a fulltime remote role based in the Central or Eastern time zone requiring 40 travel.
As the Staff Internal Quality Auditor you will be responsible for working collaboratively with key stakeholders from new and existing Global Quality and Operations (GQO) Stryker sites in the planning and reporting of Internal Audits. You will quickly build strong relationships throughout Strykers global footprint. You must possess very strong written and oral communication skills and be able to report findings throughout all levels of the organization in a collaborative and factbased manner that is conducive to building strong partnerships. A keen understanding of the highly regulated environment great attention to detail and the ability to make important decisions independently are requirements of the position.
What you will do
Lead Internal audits independently from planning closure reporting and postaudit followup
Plan and tailor the audit agenda and scope based on feedback and information received from the site being audited
Interpret and provide guidance on applicable regulations such as FDA ISO MDD and Stryker policies
Assist in the coordination of Stryker Internal Audit program to ensure compliance to quality system requirements
Present audit results and correlating data to key stakeholders at the site location
Escalate emerging trends of audit findings to identify areas for improvement
Interface with Site RAQA Heads GQO Quality Management and International RAQA Management where applicable
Monitor observations from external and Corporate quality audits of Stryker sites
What you need
Bachelors degree
Professional certification in Quality Auditing (i.e. Certified Lead Auditor)
4 years medical device or FDA regulatory industry experience
2 years Quality Audit experience (internal external and/or supplier)
Comprehensive knowledge of FDA regulations FDA QSR ISO 13485:2016 Medical Device DirectiveRegulation 93/42EEC) and other national and international regulations
$77200 $123700 USD salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 40Stryker 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 contractors legal duty to furnish information.Required Experience:
Staff IC
Employment Type
Full-Time
