Design Quality Assurance Engineer

Watchmaker Genomics • Boulder, CO

12h • $90,000 - $100,000 • Onsite

About The Position

Watchmaker Genomics is inviting applications for the full-time position of Design Quality Assurance Engineer. This position will be based in Boulder CO and reports to the Manager of Quality Assurance. 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). The ideal candidate will have experience supporting new product development and routine manufacturing of products within a regulated environment, a minimum of 8 years of relevant industry experience, and will thrive in a dynamic, fast-paced working environment while contributing directly to our company culture and success. This position provides an opportunity to support a first-rate ISO 13485-compliant QMS for an industry-leading, agile genomics company with a quality-conscious customer base.

Requirements

• A commitment to quality and a high level of self-motivation
• Excellent verbal and written communications skills
• Strong interpersonal skills and an ability to work as an effective member of a cross-functional team
• Ability to work independently with responsibilities and stakeholders across multiple global sites
• The ability to multitask, perform consistently under pressure, and work without supervision
• Excellent organizational skills and outstanding attention to detail
• Ability to have fun and thrive in a growing, diverse and inclusive work environment
• Bachelor’s Degree (or equivalent) or higher in molecular biology or related field required
• Minimum of 8 years of quality assurance and product development experience of reagents or biologics under design controls
• Advanced knowledge of in vitro diagnostic reagents and / or nucleic acid-based products is desired
• Preferred ISO 13485, ISO 9001, or cGMP industry experience in quality assurance, quality systems, operations, or other related fields
• Desired strong working knowledge of design controls, verification and validation principles and practices, product risk management, ISO 13485, ISO 14971
• Strong history of successful participation on cross functional and / or cross-site project teams
• Project management experience is beneficial
• Audit experience (audit host or participant, internal audit experience) in medical device/pharmaceutical company is beneficial

Nice To Haves

• Preferred quality experience with molecular biology product development, manufacturing, and support

Responsibilities

• Support a high-quality and high-performance culture across the company
• Provide design control, development, and transfer guidance as a core member of new product development teams
• 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
• Participate in design, implementation, and maintenance of new product development and design transfer procedures, work instructions, templates, and tools to facilitate and ensure design control compliance
• 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

• Employees are eligible for 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, and a 401(k) retirement plan with a 4% match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level