Genomic Health

Position Overview

We wish to recruit an experienced, hands-on Senior Quality Associate with an established background in the diagnostics industry, who is able to apply clinical laboratory quality principles (ISO15189 / DAkkS / RiliBAEK) within a professional setting. The successful applicant will be able to demonstrate and evidence their ability to assist individuals and groups in the creation of effective, compliant and efficient company processes.

A self-motivated individual is required as this role will lead continuous improvement initiatives within the clinical laboratory quality management system and will also work with a number of internal and external stakeholders.

The place of work is Trier, Germany. Successful candidates are expected to be able to commute to the clinical laboratory on a regular basis and be fluent in both English and German.

Essential Duties

Include, but are not limited to, the following:

• Uphold the laboratory quality management system through the development and maintenance of clinical laboratory policies and procedures whilst ensuring the clinical laboratory meets respective standards and regulations, such as ISO15189 / DAkkS / RiliBAEK.
• Lead the implementation of quality management system processes and ensure these integrate with Exact Sciences Harmonisation plans.
• Take ownership for key quality management processes within the Trier clinical laboratory as required e.g. Non-conformance, CAPA, management review, QMS training, quality metrics etc.
• Assisting laboratory management with the investigation and resolution of quality-related issues if and when they arise.
• Develop new and existing QMS processes as required to meet business needs.
• Work as part of project teams to ensure QMS and applicable regulatory requirements are met.
• Support the day-to-day requirements of the quality management system as required, including document control and record keeping.
• Lead and support internal audits as required, including facilitating required corrections and corrective action.
• Assist in the design of training programs for QMS procedure implementation.
• Train employees companywide in QMS procedures owned by QA.
• Ensure compliance with data protection best practice e.g. GDPR.
• Revise processes in line with audit findings.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Work with a ‘one company’ mindset when interacting with other Exact Sciences entities.
• Willing to support quality assurance activity outside of the Trier clinical laboratory when required including within the International business unit.

Skills

• Possesses a high degree of accuracy and attention to detail.
• An excellent understanding of the role of quality in a business context.
• Excellent presentation technique.
• Strong verbal & written communication.
• Technical ability to learn about genomic clinical testing workflows of relevance to the role.
• Ability to operate electronic QMS systems (including document control).
• Ability to work to deadlines.
• Competent in the use of standard Office software e.g. Word, Excel etc.
• A self-motivated individual is required as this role will involve frequent interaction with an accredited third party as well as other Exact Sciences locations.
• The role will also require communication with sub-contract organisations.
• Ability to act with an inclusion mindset and model these behaviours for the organisation.
• Maintain regular and reliable attendance.

Physical and Travel Requirements

• Ability to travel within Europe and America.
• Willing to travel on an infrequent basis when required by the business.
• Ability to comply with any applicable personal protective equipment requirements.

Minimum Qualifications

• BSc in a relevant scientific discipline.
• Demonstrable understanding of clinical laboratory standards and guidance such as ISO15189 / DAkkS / RiliBAEK.
• 3+ years hands-on experience supporting the development, operation, and maintenance of a clinical quality management system.
• 3+ years hands-on experience in the IVD industry or equivalent experience.
• Fluent in both English and German.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Right to work in Germany without sponsorship.

Preferred Qualifications

• Recognised qualification from a relevant quality institute e.g. ASQ CQA, CQE, Six Sigma, etc.
• IRCA qualified quality systems auditor.
• Experience with audits or inspections by regulatory / accreditation bodies.
• Understanding of Medical Device / IVD manufacturer quality management system processes e.g. ISO13485, FDA 21 CFR Part 820.
• Post graduate qualification in a relevant Scientific discipline.

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If you require a reasonable accommodation with the application process, please email hr@exactsciences.com.