Danaher Corporation Staff Quality Engineer, Quality Programs in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
Works closely with a high performing Quality team covering areas including Quality Control, Quality Engineering, Quality Assurance and Quality Systems.
Provides validation support for Cepheid facilities, manufacturing processes and equipment.
Writes Quality Plans, Validation Master Plans (VMP), Risk Management Plans, coordinate pFMEA sessions and provide assistance to other functions to complete pFMEAs
Reviews VMPs. Equipment qualification IQ, OQ, PQ, Process Validation (PV) plans, protocols, reports; writes Validation Master Summary Reports.
Actively participates in the quality planning processes; participates in strategic and tactical planning processes.
Collaborates across the organization at all levels, across functional groups and geographic locations, including management.
Communicates and reports regularly to Quality management, users and staff on progress updates.
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes.
Provides Subject Matter Expertise and assures implementation of best practices for Process Validation / Production and Process Controls functions to the organization.
Assists as representative for company’s Process Validation / Production and Process Controls process during Agency /3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies
Education and Experience (in years):
Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 3-9 years of related experience OR
Master’s degree in field with 7 years of related work experience
Knowledge and skills:
Medical Device industry experience, preferably IV
Strong understanding of Facilities, Equipment Installation, Operational and Performance Qualifications and Validations, Process Validation / Production and Process Controls.
Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, ISO 13485, ISO 14971 and other applicable standards and regulations
Training and certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
Experience in Manufacturing Operations
Experience with participating in audits
DBS, LEAN or Six Sigma operational excellence training or certification
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid