Senior Design Quality Engineer
- 153 Townsend St, San Francisco, CA 94107, USA
We’re a cutting-edge tech company with a very human mission—to help every person discover, preserve, and share the story of what led to them. Combining the rich information in family trees and historical records with the genetic details revealed in DNA, we create unique experiences that give people a new understanding of their lives, because connecting all the pieces of our family story can give us the deepest sense of who we are.
For more information on what we do and why you would want to work at Ancestry, visit our careers page:www.workforancestry.com
- As an interface between quality, Genomic Science, Laboratory Science, Operations, and Software Engineering you accompany the development of IVD products by ensuring the accurateness of the applicable quality-related structures and regulations.
- In close cooperation with the process owners for design control, who are located across sites, you ensure that all processes meet the international requirements and all necessary approval methods along with all documentation standards are established.
- You analyze and supervise the compliance of procedures by verifying development records, design transfer protocols, validation reports and risk analysis and initiate corrective actions as necessary.
- The introduction and monitoring of quality key data across sites regarding design control and risk management are part of your area of responsibility as well as independent creation and processing of reports and evaluations in order to encourage and support continuous improvement activities.
- You are an engineer in the field of bioengineering, medical technology or have a degree in an equivalent subject of study.
- You know the medical devices norm ISO 13485 very well and have at least 3 years of experience in quality management, ideally in the medical device industry and/or In Vitro Diagnostic industry.
- Moreover, you are familiar with QSR and have knowledge of Reagents and Assay technology
- You have very good English skills, have had experience in project management and are familiar with the typical MS Office applications.
- Your team orientation, strong communication skills and your assertiveness along with a high-quality awareness and an independent work style complete your profile.
- Bachelor degree or equivalent in a technical area.
Background and Experience:
- Three (3) years of progressive Design Control background in In Vitro Diagnostics (IVD) and medical device industries, with a hands-on role in quality operations and quality systems
- Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, CFR 809 (IVDD), ISO 13485, etc.
- Experience with MasterControl a plus
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.