Location
Trier | Germany
Job description
Help us change lives
At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
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.
- 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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Standort
PreventionGenetics, Trier
Job tags
Salary
