Overview
Device QA Engineer Jobs in Sunnyvale, CA at Capgemini
Who We Are:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
The QA Supervisor will coordinate with the Manager/Associate Director, Quality Assurance, the day-to-day activities of the Quality Assurance group in the support of the site’s Operations (manufacture, testing, shipment, etc.). This person will evaluate and implement systems, methods, techniques, and solutions to moderately complex quality and regulatory compliance issues, and be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership. Additionally, this role will assist with regulatory agency and client audits and monitor the implementation of any preventative and corrective actions. The QA Supervisor must have a thorough understanding in ICH guidance, FDA regulations, GMPs, and Quality Systems relevant to the manufacturing of pharmaceuticals. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations.
Core Responsibilities:
Define operational excellence locally to align with global objectives. Lead and influence teams of people internally and externally to meet QA Operations objectives.
Build and strengthen Veranova’s quality culture and compliance reputation through functional excellence and involvement in organizational forums.
Provide talent development and mentorship. Manage and provide guidance to the QA team supporting GMP manufacturing activities, batch record review, and batch release.
Educate staff on Quality practices, including new hire quality orientation and compliance training.
Coach, mentor and develop QA staff.
Provide quality expertise, and oversight of manufacturing processes across shift operations to ensure adherence to GMP standards.
Evaluate complex quality or multi-disciplinary situations and make decisions utilizing risk-based approach. Oversight of CDMO performance to compliance and Quality Agreement expectations.
Responsible for Quality oversight to support the manufacturing and release of products, ensuring these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.
Ensure timely and effective communication with clients on Quality topics, addressing any concerns and providing updates on ongoing quality issues or regulatory matters.
Participate in the review and approve controlled documents, including deviation, change control, CAPA reports, batch records, SOPs, and product and material specifications.
Participate in the conducting and reviewing of product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
Prioritize work efforts to ensure adequate Quality resources are in place to meet all business functions, working proactively and reactively to meet business demands.
Other duties as assigned.
Qualifications:
Required
Minimum 9 years of quality assurance experience with an undergraduate degree in engineering, science or related field
Minimum 7 years of quality assurance experience with a graduate degree in engineering, science or related field
Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
Excellent analytical, written and verbal communication and presentation skills
Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
Proven experience working effectively in team situations and as an individual contributor
Demonstrated behavior that models the Veranova culture to achieve an inclusive environment and exceptional business results
Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
Previous people management and/or team leadership experience required
A mindset that promotes a positive work culture.
Preferred
Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.
Our Commitment:
Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to [email protected] in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.
Legitimate LinkedIn communications will only come from active Veranova employees.
Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).
Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).
If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: [email protected] (US) or [email protected] (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
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Title: Device QA Engineer
Company: Capgemini
Location: Sunnyvale, CA
