Head of Quality Assurance
- Lehi, UT, USA
Oversee the development and implementation of a Quality Management System consistent with U.S. FDA and global regulatory requirements, e.g., ISO13485, QSR, IVDD, MDD and CMDR and other global regulations, as applicable to medical devices and IVDs for a new business entity.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Lead the development, implementation and maintenance of a quality management system compliant with applicable global regulations for a complex manufacturing, laboratory and software system
- Develop and lead a team that meets the QA/QC/Regulatory compliance needs of the business, including hiring, training, planning and execution
- Build required regulated systems and processes bridging regulated and non-regulated systems with business efficiencies
- Lead an existing company into regulatory compliance by engaging stakeholders in developing processes and procedures, communicating requirements to functional areas, training employees.
- Lead, develop and implement global quality strategies that ensure operations meet applicable regulations in key markets
- Ensure Supplier quality plans, qualifications
- Familiarity with Software V&V, clinical laboratory standards including CLIA, CE Mark
- Oversee the conduct of internal audits in compliance with the US FDA QSR, the European MDD, Canadian CMDCAS and ISO13485
- Quality gap analysis internally and with supplier manufacturers and labs
- Ensure accurate documentation is made available for submission to FDA and Notified Body, design dossiers, technical files, post-market submissions and other regulatory documents
- Act as team leader in formal ISO audits, CE recertification and FDA inspections
- Oversee the development and implementation of electronic document management system and tracking databases to ensure prompt and accurate access to company quality and regulatory information
- Prepare and communicate reporting to functional and executive levels on status, exceptions and planning
- Prepare and adhere to a budget
- Participate in strategic planning and tactical implementation
- Function as a competent leader and team member at corporate and operational levels
- Leadership skills encompassing quality and business perspectives
- Ability to lead the development of compliant complex processes and work flows
- Overall responsibility for quality system documentation system
- Comprehensive knowledge of Quality Assurance methods and tools
- Extensive experience with US FDA regulations and compliance Class II Medical Devices, with IVD experience highly preferred
- Extensive experience with the European Union, MDD and ISO compliance
- Possess excellent interpersonal, leadership, analytic, problem-solving and persuasive skills
- Ability to interface with both technical and non-technical personnel
- Minimum 12 years in Quality Assurance or Quality Control in a medical devices/IVDs, with preference given to IVD experience
- Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements
- Experience with additional international regulations preferred
Bachelor’s or Masters degree in engineering scientific discipline or engineering
ASQC or similar certification preferred
Ancestry is a profitable, growing company with a positive, high-energy environment. Together, our dedicated teams are harnessing the power of technology and using it to simplify the way people connect with their families and their unique legacies. Our work environment is fast-paced and challenging, but also extremely exciting. You’ll work with a team of passionate, engaged individuals. We offer excellent benefits and a competitive compensation package. For additional information, regarding our benefits and career information, please visit our website at http://ancestry.com/careers
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.