Senior Quality Engineer I - Combination Product Development
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Job Location:
Foster, CA - USA
Monthly Salary:
$ 136340 - 176440
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job Description
KeyResponsibilities:
- Serve as a lead quality engineer for medical device combination product development projects with a strong emphasis on design control and risk management activities.
- Collaborate with device engineering on new combination product development supporting design verification validation and transfer activities.
- Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards including FDA 21 CFR Part 820 21 CFR Part4 ISO 13485 ISO 14971 and Gileads quality system requirements. Plan and implement approved quality improvement action items and deliverables.
- Interface with internal stakeholders contract manufacturers and suppliers to resolve complex technical issues related to drug-device combination productsprocesses and quality.
- Act as an escalation point for complex and high-impact quality issues concerns and decisions.
- Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs).
- Provide guidance and impact assessments for change controls including Design History File (DHF) and Risk Management File (RMF) assessments.
- Develop and/or review controlled documents (e.g. protocols reports plans risk analyses specifications test methods).
Basic Qualifications:
- Bachelors degree in engineering or a scientific discipline with at least 6 years of relevant experience OR a Masters degree in a relevant field with at least 4 years of relevant experience.
- Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
- Excellent verbal written and interpersonal communication skills
Preferred Qualifications:
- Prior experience with combination products (e.g. autoinjectors co-packed kits pre-filled syringes) is preferred.
- Strong project management and process improvement skills.
- Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
- Possess a strong foundation in statistical techniques (e.g. normality tests capability analysis tolerance intervals) test method validation (MSA GageR&R) and risk management principles per ISO 14971 including FMEA and systems analysis. Expertise in one of these areas is required
- Ability to develop and improve complex concepts techniques standards and new applications based on quality principles and theories.
- Strong knowledge of medical devices and or combination products manufacturing.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Senior IC
Key Skills
- Joomla
- Banking
- C
- Market Research
- Bpcs
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
