Would you be passionate about improving people's lives with products that make a real difference? Then Bio-Rad's QA/RA manager role could be your next challenge!
Overview:
In alignment with European GCO strategic aims, manage the Quality and Environmental (where relevant) system for Benelux and Nordics Selling Organisation:
to ensure Sales business is conducted in compliance with all applicable regulatory, quality and environmental requirements,
to promot... Visa mer
Would you be passionate about improving people's lives with products that make a real difference? Then Bio-Rad's QA/RA manager role could be your next challenge!
Overview:
In alignment with European GCO strategic aims, manage the Quality and Environmental (where relevant) system for Benelux and Nordics Selling Organisation:
to ensure Sales business is conducted in compliance with all applicable regulatory, quality and environmental requirements,
to promote best practices, to achieve organisational efficiencies, to ensure customer satisfaction and optimal value to the business.
Be an active team member building European QMS.
Key Responsibilities:
Management of Quality and Environmental (where relevant) System Implementation and maintenance of Quality and Environmental Management Systems (e.g. ISO 9001, ISO 13485, ISO 14001, IVDR) 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
Keep informed about regulatory changes for the different countries
Ensure that the following activities are managed effectively in Nordics and Benelux :
Critical records are maintained in compliance with company and regulatory requirements.
Support the declaration of WEEE and others (lamps, batteries, packaging waste, chemicals) in a timely manner
Involved in Benelux and Nordics projects according objectives (acquisition, new organisation, new system…)
Active European QA/RA team member and get involved in projects according to objectives
Participation to the internal European GCO audit program
Involved in project according objectives to build & maintain the European QEMS
Travels in Benelux, Nordics and UK and in Europe as GCO European team member
Key qualifications are:
Professional education in quality, regulatory & commercial areas
Internal auditor, experience in ISO procedures (9001, 13485, 14001), optionally IVDR & medical device issues
Leadership skills, analytical (thinking) skills and solid decision making skills, independent working, accurate, flexible, proactive, communicative, team player, customer-oriented, ability to listen and to propose good sense decisions
Fluent English language, Swedish as a native language. Dutch and Nordics languages as optional.
Other important personal attributes include; Good organizational and time management skills; a strong ability to work both independently and contribute in a team environment and; flexibility in changing priorities in a fast-paced environment.
About Bio-Rad:
Bio-Rad is a global leader providing a broad array of clinical and live science research products. With a team of more that 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
To learn more about Bio-Rad, please visit: www.bio-rad.com
Application:
If you are interested in this position, please apply with an updated CV in English The selection process will be ongoing and interviews are held continuously, so please send in your application as soon as possible.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Agency Non-Solicitation:
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
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