Position: Design Quality Assurance Engineer

Department: Quality Assurance

Position Type: Full-Time Employee

Location: Cape Town, South Africa

Experience: Bachelor’s Degree (or equivalent) in Molecular Biology, Process Engineering, or a related field is required; advanced degrees are preferred and 5+ years relevant experience.

Position Summary

Watchmaker Genomics is inviting applications for the full-time position of Design Quality Assurance Engineer.

We are seeking a Quality Assurance professional to join our dynamic team in Cape Town, reporting to the Manager of Quality Assurance. In this role, you will play a key part in supporting the design, development, transfer, and routine manufacturing of Watchmaker’s innovative products, all within our ISO 13485-compliant Quality Management System (QMS).

The ideal candidate will have at least 5 years of relevant industry experience, with proven expertise in managing the product lifecycle in an ISO 13485 environment. We are looking for a pragmatic, detail-oriented individual with a solid understanding of risk management and a passion for driving continuous improvement and operational excellence. This is a unique opportunity to contribute to a world-class QMS for an industry-leading, agile genomics company that values quality and customer satisfaction.

Core Responsibilities

• Foster a high-quality, high-performance culture throughout the organisation.
• Build and maintain strong, effective, and collaborative relationships with key departments, including R&D, Process Development, Commercial, Project Management, and Operations.
• Serve as a key member of new product development teams, providing expertise and guidance in product design control, development, and transfer.
• Review and approve activities and documentation to ensure compliance with design control requirements and international standards, including all aspects of product development—design planning, inputs, outputs, reviews, verification and validation, design transfer, and change management.
• Participate in project milestones and review gates to confirm that product designs and projects meet all requirements to advance to the next phase.
• Contribute to the creation, implementation, and continuous improvement of procedures, work instructions, templates, and tools to support design control compliance during product development and transfer.
• Assist in nonconformance (NC) investigations and design change impact assessments.
• Lead and participate in internal audits as either a lead auditor or co-auditor.
• Act as a subject matter expert for design quality assurance during external or third-party audits, further serving as audit host or scribe.
• Prepare, analyse, and present routine QMS metrics and reports for management and stakeholders.
• Support quarterly and annual Management Reviews, ensuring that all quality metrics are reviewed and action plans are developed.
• Assist with global, multi-site validation activities, including process, test method, computer systems, and equipment validation, providing compliance support, protocol reviews, and approvals.
• Review and approve quality-related documents, records, and reports, including NCs, CAPA investigation reports, change requests, certificates of analysis, and batch records.
• Lead improvement projects derived from NCs, CAPAs, internal audits, or departmental goals, driving them to successful completion.
• Assist with the company’s training program by developing and delivering training content.

Education and Experience

• Bachelor’s Degree (or equivalent) in Molecular Biology, Process Engineering, or a related field is required; advanced degrees are preferred.
• A minimum of 5 years of experience in quality assurance and product development, specifically with reagents or biologics under design controls. Advanced knowledge of in vitro diagnostic reagents and/or nucleic acid-based products is highly desirable.
• Proven experience and aptitude in troubleshooting, root cause analysis, and technical investigations.
• Preferred experience in ISO 13485, ISO 9001, or cGMP environments, particularly in quality assurance, quality systems, or operations.
• Strong working knowledge of design controls, verification and validation principles, product risk management, ISO 13485, and ISO 14971 is highly valued.
• A successful track record of working on cross-functional and/or cross-site project teams. Project management experience is an advantage.
• Audit experience, whether as an audit host, participant, or internal auditor in the medical device or pharmaceutical industry, is beneficial.

Required Knowledge and Abilities

• Strong commitment to quality, with a proactive and self-motivated approach.
• Excellent verbal and written communication skills, with the ability to convey complex ideas clearly and effectively.
• Strong interpersonal skills, enabling you to collaborate effectively within cross-functional teams.
• Pragmatic mindset with the ability to critically assess and implement effective strategies for troubleshooting and investigations, using risk-based approaches.
• Solid experience in molecular biology product development, manufacturing, and quality support is highly desirable.
• Ability to work independently, managing responsibilities and coordinating with stakeholders across multiple teams and/or sites.
• Exceptional organisational skills with the ability to multitask, manage priorities, and perform well under pressure.
• Impeccable attention to detail, ensuring accuracy and consistency in all work.
• Ability to lead and complete projects independently while driving continuous improvement efforts.
• A passion for fostering a culture of quality, operational excellence, and innovation.
• A positive, adaptable mindset with the ability to thrive in a fast-paced, growing, and diverse work environment—while having fun along the way.

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.

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.

To ensure your application is considered, please submit it by Friday, 27 September 2024. Please note that this position may close earlier if we receive a high volume of applications. We encourage you to apply as soon as possible.

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SOUTH AFRICA - 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 South Africa; and if now or in the future will require visa sponsorship to continue working in South Africa.

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 laws.