Do you thrive in an environment with diversity, communication, collaboration, and teamwork as the core values?
Are you ready to ensure the highest quality standards in the development and manufacturing of in-vitro diagnostics and medical devices?
As the Quality Assurance Manager, you will be responsible for establishing, training, and implementing an ISO 13485 and FDA QSR Quality System. The position is responsible for providing quality expertise as well as creating, reviewing, and approving documentation to ensure compliance with internal procedures and regulatory requirements for in-vitro diagnostics and medical devices.
WHAT YOU WILL BE DOING
- Provide quality compliance guidance throughout the implementation and improvement of the Quality Management System (QMS), including new product development, product changes, and other internal projects.
- Communicate quality goals and issues with technical and supporting team members, as well as management, and assist with decision-making processes on project and deliverable execution.
- Update Executive Management on the status of the QMS, ensuring compliance with all regulatory standards and promoting a culture of quality excellence within the organization.
- Support all QMS activities, including Document Control, Training, CAPA, NC, QC, QA product release, Process Validation, Audits, Management Review, and Recalls.
- Continuously improve the QMS to adapt to evolving business needs.
- Lead internal and external audit activities and implement and perform acceptance activities, including incoming, in-process, and final inspection.
- Review and approve documentation for compliance with US, EU, and other international regulations, and approve components and finished products for final release.
- Identify and manage areas of potential noncompliance; ensure that any non-conformances or deviations are properly approved and documented.
- Interact with and coordinate with employees in a global company to support business unit objectives.
ABOUT YOU
- Strong analytical, problem-solving, and root-cause analysis skills.
- Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations.
- Driven individual with a history of developing collaborative, cross-functional solutions.
- Does not cut corners or bow to external pressure to compromise on requirements.
- Proactive and self-motivated with a passion for maintaining high-quality standards.
WHERE YOU WILL WORK
- This position is based in our headquarters in San Jose, California.
- Up to 20% travel may be required for audits, conferences, and meetings with global collaborators.
WHAT YOU WILL BRING US
- 6+ years’ experience in a quality engineering or assurance role at an IVD or MD manufacturer.
- Knowledge of US (21 CFR 820) and EU (ISO 13485) quality system requirements.
- Working knowledge of common computer software applications (SharePoint, SAP, WORD, EXCEL, Adobe Acrobat, etc).
- 8+ years’ experience in design quality engineering and/or manufacturing quality engineering preferred.
- Experience leading product development, design transfers, process validations, or CAPAs highly preferred.
- Prior experience in in-vitro diagnostics or molecular diagnostics highly preferred.
WHAT YOUR EDUCATION LOOKS LIKE
- Minimum BA/BS in a scientific discipline.
- Preferred: BS degree in Engineering, Molecular Biology, or Biochemistry.
- Preferred: Lead Auditor experience per ISO 13485 and/or FDA QSIT audits preferred.
HOW WE WILL REWARD YOU
The base salary range for this position is $140,000 - $160,000. This position is eligible to earn incentive compensation that is calculated and paid in accordance with the applicable annual bonus plan.
- Annual gym membership reimbursement to keep you healthy.
- Employee discount program to save you some money.
We offer eligible employees and their dependents (including domestic partners) a comprehensive and competitive benefits package. Complete Genomics contributes to the benefits package.
- Medical, Dental, and Vision Coverage
- Life and AD&D Insurance
- Long-term and Short-term Disability Insurance
- Voluntary Life and AD&D Insurance
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSA)
- Domestic Partner Benefits
- Commuter Program
- Employee Assistance Program
- 401(k) Retirement Plan
- Education Assistance
- 20 PTO days and 11 holidays per year
Complete Genomics provides equal employment opportunity without regard to race, color, religion, sex, national origin, sexual orientation, gender identity and/or expression, age, disability, veteran or uniformed service status, or any other characteristic protected by applicable law.
