|Manager, Product Lifecycle Quality|
Location: Sunnyvale, CA
Employment Type: Full Time
Date Posted: 05/13/2021
Expire Date: 06/12/2021
Job Categories: Accounting/Auditing, Engineering, Healthcare, Practitioner and Technician, Human Resources, Manufacturing and Production, Executive Management, Quality Control, Research & Development, Medical
Manager, Product Lifecycle Quality|
1. Manage a group of quality specialists/engineers to support design quality related activities and assure compliance with design control regulations. Ensure the teams development of skill sets to enable team members to provide guidance for Design Inputs, Design Verification, Design Validation, Test Method Validation, Manufacturing Process Validation, Risk Management, and Design Reviews. Serves as Quality representative to project core teams as needed.
2. Strategize product development activities and resourcing. Resolve potential design control issues, taking into account both regulatory and business impacts to ensure continued quality compliance and support of business needs.
3. Collaborate with Manufacturing Quality and Post-Market Quality to support post-commercialization investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.
4. Work with management and cross-functional teams for continuous improvement of the Quality Systems, including the risk management, design control, document generation, and design testing processes.
5. Effectively communicate and maintain visual tools for project tracking and management. Effectively employ Danaher Business System (DBS) tools and concepts to maximize efficiency and quality. Develop metrics and scorecards to measure quality level performance within the design and development process.
Complete all assigned and required training satisfactorily and on time. Ensure associates attend and complete all required trainings satisfactorily and on time, and continually update training curriculums as needed.
Education and Experience:
1. Bachelors degree in Chemistry, Biology, or related physical or biological science field, with 5+ years of experience; or
2. Masters degree in Chemistry, Biology, or related physical or biological science field, with 3+ years of experience.
Knowledge and Skills:
1. Experience with people management, with emphasis on relationship development, within design quality in a medical device industry.
2. Expertise with the domestic and international medical device regulatory environment, include the CE Mark, 510(k)/PMA process and approvals, FDA audits, design control guidelines.
3. Intermediate to advanced skill level in Minitab, MS Word, Excel, Visio, PowerPoint.
4. Excellent problem solving and analytical skills.
5. Able to think critically and strategically in a fast-paced, cross-functional environment. Excellent written and oral communication abilities.
6. Strong analytical and technical skills.
7. Motivated self-starter, capable of achieving objectives in a demanding environment.
8. Detail-oriented, accurate, organized while delivering on commitments efficiently and on time.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.