Watchmaker Genomics is inviting applications for the full-time position of Design Quality Assurance Engineer. The successful candidate will be responsible for supporting the development, transfer, and routine manufacturing of Watchmaker’s products, within the context of our ISO 13485-compliant Quality Management System (QMS).
Requirements
- Support a high-quality and high-performance culture across the company
- Establish and maintain good working relationships with partner departments, including R&D, commercial, process development, project management, and production
- Review and approve activities and documentation consistent with design control requirements and international standards dealing with product development, including design and development planning, inputs, outputs, reviews, verification and validation, design transfer, and design change procedures
- Participate in project milestones and review gates to determine if a product design and project has met the requirements to proceed
- Complete internal audits as a lead / co-auditor
- Support external / third party audits as design quality assurance subject matter expert, audit host, and / or audit scribe
- Prepare and analyze routine QMS metrics and reporting for the business
- Support quarterly and annual Management Reviews
- Support global (multi-site) validation activities (process, test method, computer systems, equipment), including program / process content and compliance support, protocol and record review and approval
- Review and/or approve quality documents, records and reports including nonconformance and CAPA investigation reports, change requests, certificates of analysis, batch records
- Lead improvement projects to completion that may be initiated from nonconformances, internal audits, site, or department goals
Benefits
- Flexible Time Off
- Holidays
- Employer covers 75% of base medical plan with buy-up options
- Employer paid dental
- Employer paid vision
- Employer paid $25,000 life/AD&D policy
- Paid parental leave
- 401(k) retirement plan with a 4% match
