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 preferred place of work is Trier, Germany. Remote work can be offered if candidates are able to commute to the clinical laboratory on occasion as required. The role requires fluency in 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.
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.

Physical and Travel Requirements

Ability to travel within Europe and America.
Ability to comply with any applicable personal protective equipment requirements.

Minimum Qualifications

BSc in a relevant scientific discipline.
Understanding of clinical laboratory standards such as ISO15189 / DAkkS / RiliBAEK.
3+ years hands-on experience supporting the development, operation, and maintenance of a 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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Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging.

Standort

Genomic Health, Inc., Trier