- Do you have experience managing and implementing Quality Management Systems?
- Are you ready to be part of the Management Team, assuring Quality standards?
Our client, Bio-Rad Laboratories, has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Founded in 1952, they have a global team of more than 8,250 employees and serve more than 150,000 research and industry customers worldwide through their global network of operations.
Due to strong performance in 2018 and planned growth in 2019, Michael Page are currently looking to recruit a QA&RA Manager, operating from the Stockholm area, due to cover the Benelux & Nordics region. The successful candidate will report into the EMEA QA&RA Manager and become part of a growing European-wide team. The successful candidate will become a key member of the Management team, leading Quality & Complaint Management responsibilities.Arbetsbeskrivning
As Bio-Rad Laboratories' QA&RA Manager for the Nordics & Benelux regions, the successful candidate's responsibilities will include - but might not be limited to - the following:
Management of Quality and Environmental Systems
- Member of the Nordic & Benelux Management Team, managing & driving all Quality related responsibilities
- Implementation and maintenance of Quality and Environmental Management Systems (e.g. ISO 9001, ISO 13485, ISO 14001) in accordance with European GCO strategy and Benelux and Nordics business needs
- Pilot the quality documents process: Q&E manuals, SOPs and work instructions
- Conduct working groups to implement improvements into applicable procedures; follow-up their implementation and their efficiency with the appropriate indicators
- Responsible of the Quality and Environmental Management Review organisation with the local Managers : propose a Q&E policy related to the company objectives, change of organization , change of external regulations, lead the review and follow the realizations of the actions decided by the managers
- Train newcomers and organize on a regular basis, refresh sessions on Q&E Management System
- Identify improvement opportunities by conducting internal audits and through the analysis of customer feedback data and KPI. Support the business to define corrective actions and improvement activities
- Manage external audits by regulatory bodies and customers
- Participate and assist in business risks management activities
- Ensure that Quality and Regulatory obligations of channel partners are managed effectively
Management of Customer Complaints
- Ensure that customer receive in a timely manner appropriate answers to their complaints
- Support local organizations in their reviews of issues raised by customers
- Provide oversight of the local customer complaint management process and optimize product quality feedback to Bio-Rad's manufacturing divisions
- Manage Field Actions according to Bio-Rad Global procedures
Management of Regulatory Affairs
- Ensure that the following activities are managed effectively in Nordics and Benelux :
- Critical records are maintained in compliance with company and regulatory requirements
- Declaration for WEEE and others (lamps, batteries, packaging waste, chemicals) in a timely manner
- Involved in Benelux and Nordics projects according to objectives
- Participation to the internal European GCO audit program
Involved in project according objectives to build & maintain the European QMS/ EMS.Vem söer vi?
In order to be successful in this recruitment process, candidates are expected to fulfill the following requirements:
- Ability to travel regularly across the Nordics and Benelux region
- Fluency in both Swedish & English, written and spoken, is a must
- Command of any additional Nordic language and/or Dutch is highly meritorious
- A strong background in Quality Assurance, preferably from the MedTech and/or Pharmaceutical industries
- A strong academic background in a relatable field, preferably in Quality, Regulatory & Commercial areas
- A background as Internal Auditor with a solid command of ISO procedures (e.g. 9001,13485,14001)
- A service-minded and "can do" attitude
If you have strong stakeholder management skills, are communicative and self-driven this could be the perfect opportunity for you. Our client is looking to offer a competitive compensation to the successful candidate.
Ansök till Quality Assurance / Regulatory Affairs Manager
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Audits, ISO 9001, Management, Network