Senior Quality Associate, Germany
vor 7 Monaten
**Position Overview**
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.
**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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