The Design Quality Assurance (DQA) Manager works with key stakeholders to ensure that Roche procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during product development and product care. In this position you will have active membership in local and global multi-disciplinary project and product teams, which span several time zones.
In addition, there are the following main responsibilities:
- You support teams to achieve sustainable compliance with medical device regulations in the development of new products and maintenance of on market products covering component, system (Instrument Hardware, Software and Consumables or Standalone Software), and/or assays.
- Working with Research & Development, you assist in the planning of design control deliverables or outputs to ensure that product stewardship, quality, manufacturability, serviceability and reliability are addressed in the design stages of new product development.
- Managing the DQA activities with a proactive, business solution oriented approach, you promote a culture of quality awareness, teamwork and collaboration with all involved in the generation, review and approval of design control documentation and records during product development and product care activities.
- To ensure or improve product safety and effectiveness, you work with teams to investigate issues, identify root causes and implement robust and effective corrective and preventative actions.
- Cultivating and maintaining effective relationships with key stakeholders, you empower business by positioning DQA as an embedded and integral part of global cross-functional project teams through continued education and integration of quality topics in the business.
- You actively participate in knowledge management, and contribute to continuous process improvement initiatives.
The advertised position offers:
- Membership in an international family of a global employer of choice that promotes personal and professional growth in a collaborative and stimulating workplace
- Opportunities to leverage your technical expertise and passion for compliance in engaging with stakeholders in global and cross-functional project and product teams to ensure safe and effective products for patients
- Broad exposure to the leading technologies and resources in the medical device industry that enable you make your mark
- An environment where both technical expertise and influential collaborative skills are required to achieve successes
To be successful in this role (you have to be someone with):
- University Degree in a technical/scientific discipline e.g. Chemical, Physical or Biological Sciences, Pharmacy, Microbiology, Medical (Device) Technology or Engineering
- A minimum of three years working experience in a quality, technical product support or development role, and functioning in a matrix-managed environment and a track record of good stakeholder management
- Quality Management training in 21 Code of Federal Regulations 820, ISO 13485 and related standards (certification desired but not required) or evidence of proven skills and work experience in medical device development and related technologies (molecular diagnostics, sequencing or polymerase chain reaction)
- A flexible and team-oriented personality with the ability to assert oneself, professional communication skills, and the ability to work under pressure in a fast-paced international environment
- Excellent verbal and written communication skills in English and German