Quality Systems Manager
- Lehi, UT, USA
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Ancestry is looking for a Quality Systems Manager, a Systems level thinker encompassing quality and business perspectives, who has the ability to dissect and analyze processes and work flows while working in a fast paced, exciting team environment.
ESSENTIAL DUTIES & RESPONSIBILITIES:
-Develop and maintain a quality management system consistent and compliant with applicable regulations such as US FDA-QSR, IVDD/IVDR, CMDR, ISO13485 to ensure compliance and successful MDSAP audit. -Manage the following QMS processes:
- Document Control
- Records Management
- Supplier Quality Management including supplier production and process control
- Design Control
- External audit and third-party audits by leading the team in formal ISO audits, CE recertification and FDA inspections
- Handling of complaints investigations, including analytics/trending for signal detection with investigation of root cause and subsequent corrective actions and closure.
- MDR and adverse event reporting/vigilance
- Internal audit process (by arranging, conducting, performing, reporting and closure
- Corrective and Preventive Action Program (CAPA) assuring timely data entry and reporting.
-Develop/approve and implement global QMS strategies that ensure operations meet applicable regulations in key markets/geographies
-Maintain regulatory files to ensure prompt and accurate access to company regulatory information
- Minimum 7 years in Quality Assurance or Quality Management Systems in medical devices, with preference given to IVD experience
- Thorough working knowledge and implementation experience of US FDA-QSR, IVDD/IVDR, MDD/MDR and ISO 13485
- Experience writing quality system SOP and Work Instruction documents
- Working knowledge of basic Quality Assurance methods and tools
- Experience in compliance and participation in inspection and audits with US FDA, Notified Body, Registrar, etc.
- Class II or III Medical Devices experience, with IVD experience preferred
- Possess excellent interpersonal, analytic, problem-solving and persuasive skills
- Ability to interface with both technical and non-technical personnel
- Proficiency in MS Word, Excel, Visio, Power Point and Access
- Bachelor’s degree in engineering or a scientific discipline; MS preferred
- ASQ-CQE, CQA, CBA, CMQ/OE or similar certification preferred
Ancestry is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Ancestry via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Ancestry. No fee will be paid in the event the candidate is hired by Ancestry as a result of the referral or through other means.
Ancestry is an Equal Opportunity Employer that makes employment decisions without regard to race, color, religious creed (including religious dress and grooming practices), national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and medical conditions related thereto), sexual orientation, gender, gender identity and expression, age (40 and older), mental or physical disability (including HIV and AIDS), medical condition (cancer and genetic characteristics), veteran status, citizenship, marital status, genetic information, or any other basis that is prohibited by applicable law. The Company also makes reasonable accommodations to applicants or employees with qualifying disabilities who request them and who otherwise meet the requirements of applicable law. If you would like to request an accommodation during the application process, please contact our Director of Recruiting.
All job offers are contingent on a background check screen that complies with applicable law. For San Francisco office candidates, Ancestry will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of San Francisco's Fair Chance Ordinance.