Design Quality Assurance Engineer

Position: Design Quality Assurance Engineer Department: Quality Assurance Position Type: Full-Time Employee Location: Boulder, Colorado Experience: Bachelor's degree required and 8+ years relevant experience Position Summary 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. 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 Skills and 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 Preferred quality experience with molecular biology product development, manufacturing, and support 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 Education and Experience 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 Compensation The base compensation for the Design Quality Assurance Engineer role if based in the United States starts at $90,000-$100,000 + bonus + equity; actual pay will be adjusted based on skills and experience. 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. Application Requirements To apply for the position, please submit the following in a PDF format on watchmakergenomics.com: Letter of motivation (upload where it says cover letter) Resume or Curriculum vitae, highlighting relevant qualifications and experience Applications without a Letter of Motivation will not be considered. Local candidates preferred. Applications will be accepted on a rolling basis and the position will remain open until filled; however, early submission is encouraged as review will begin immediately. If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested. *** NO RECRUITMENT AGENCIES PLEASE We are only accepting direct applications for this position. We are not working with external recruiters or agencies at this time. Unsolicited resumes or candidate submissions from third-party recruiters will not be considered and will be deemed the property of Watchmaker Genomics. *** WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law. All applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States. This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.