Manager of Quality Systems
il y a 4 semaines
IDT is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives._
We are currently looking for a **Manager of Quality Systems (EMEA)** for Leuven, Belgium. 70 % remote work possible.
Essential Functions**
- Primarily maintains overview of QMS activities and provides direct support by processing of quality events, training materials and documentation depending on workload needs.
- Reviews and approves local in-process and completed quality event records as well as SOPs for accuracy and completeness.
- Actively participates in the local IR/CAPA board for investigation, action planning & follow-up.
- Supervises and directs the Quality Assurance staff at the European headquarters which would include employee hiring, training, evaluations, and discipline.
- Acts as quality systems liaison to large customer base to coordinate audit, complaint handling and other regulated product needs for the European headquarters. Answers in official capacity for customer, regulatory and agency audits when needed.
- Works with the GMP department, other impacted departments, and customers to plan for and meet customer & quality systems requirements.
- Assists global QA management in the implementation and management of the company’s comprehensive QMS based on local needs, in compliance with ISO 9001 and ISO 13485 as applicable.
- In the absence of the Manager International Quality Systems, acts as Deputy Management Representative for the European headquarters, to promote compliance with all aspects of QMS. Advises and reports to local, QMS and global management on local quality system operations including periodic reporting on performance and recommendations for improvement.
- Manages the functionality of the quality management information systems software (QMIS) for the local site
- Assists in establishing the methods used in and the facilities for, the implementation and effective control of manufacturing processes to produce oligonucleotides reagents (a component to a medical device) for inclusion in customer designed in-vitro diagnostic (IVD) test kits/systems.
**Job Qualifications**
- Bachelor's degree in related field required.
- Quality Internal Auditor experience (accredited course completion or certification) required.
- At least 3 years of professional experience in a quality assurance, GLP or cGMP environment are required. First experience with mentoring/people management is an advantage.
- Proficiency in a variety of PC software programs/databases with strong working knowledge of Microsoft Office is required.
- Comprehensive knowledge of Quality Management Systems - ISO 9001/13485 standards is strongly preferred. Knowledge of FDA QSR/cGMP standards is an advantage.
- Speaks, reads, and writes fluently in both Dutch and English.
- Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with customers and all levels of employees and management.
- Experience in Team Leadership
- Ability to adhere to all company policies including those regarding security, passwords, and confidentiality.
- Knowledge of departmental audit and/or compliance policies, practices, and procedures.
**What do we offer**
An upbeat, open minded, international and dynamic environment is where we wish to welcome you. A close follow up and extensive training is how we wish to guide you. As a growing international company, we reward our associates with an attractive compensation and benefits package of which the details are outlined below.
- Competitive salary
- Contract of indefinite duration
- Full time (40h per week)
- Group insurance (including pension plan, guaranteed income)
- End of year premium
- Bonus system
- Up to 32 days of time off per year
Interested? Well, there is more To realize IDT’s potential, we invest in your potential. Opportunities will cross your path, enabling you to develop your career the way you want it.
All this within a cheerful and highly modern setting.
**Job Types**: Full-time, Permanent contract
**Benefits**:
- Company car
- Company computer
- Company phone
- Food allowance
- Life insurance
Schedule:
- Flexible hours
Supplemental Pay:
- 13th month salary
- Commission pay
- Yearly bonus
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