Quality System Specialist - 1 year fixed term - Bio-Rad Laboratories : Job Details

Overview:

The new colleague will support Bio-Rads commitment to quality and safety by managing activities related to the review, evaluation and investigation of escalated customer complaints related to Bio-Rads Life Science Group product portfolio.

How You will make an impact:

• Evaluation of incoming case escalations to assess the need for further investigations;
• Determine the appropriate timeline, strategy and controls needed to process case escalation requests;
• Resolve and respond to case escalations according to established company procedures and applicable standards/regulations;
• Ensure escalation activities are adequately documented including required follow-up with regional/global customer technical support teams as needed;
• Support cross functional teams and stakeholders as it relates to the needs of the case escalation and/or assigned investigational activities;
• Assess case escalations for potential reportability and/or escalation to Regulatory Affairs;
• Lead/Facilitate complaint investigations as assigned, including coordination of cross functional SMEs and product return/testing;
• Review, update, create applicable departmental work instructions, procedures and job aids as required.
• Help establish a quality environment and mindset throughout the business by managing customer complaint escalations in a timely and efficient manner, including regular communication with local/global technical support teams, product SMEs and ensuring complete and accurate documentation according to company processes and applicable QMS and regulatory requirements.
• Continuously review and improve business practices to maintain a high level of service to external and internal business partners.

What Youll bring:

• Education: Bachelors degree or equivalent Associates degree with relevant experience in a technical discipline (engineering, chemistry, biology, computer science, etc.).
• Work Experience: 2+ years experience in a life science or regulated industry or equivalent combination of education and experience.
• Basic knowledge and application or principles and theories of risk management and quality assurance or quality engineering.
• Understanding of ISO 13485 and ISO 14971 preferred.
• Knowledge of electronic quality management systems (eQMS) such as Veeva, EtQ or Arena is preferred.
• Knowledge of SFDC is preferred.
• Bringing assertiveness and confidence in their approach and collaborates effectively with stakeholders to fulfill the requirements and actions needed to resolve and close case escalations.
• Ability to work in an ever shifting environment and possess a high level of patients to support cross functional teams with shifting priorities
• A self started who is able to work independently and possesses a sense of ownership and accountability to the activities assigned to them.

Who We Are:?For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits:?Bio-Rad's biggest asset is its people, and the?reason why our Total Rewards deliver programs that provide value, quality,?and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employees work and life cycle. Were proud to offer?a?variety of?options, including:

• Life and accident insurance,
• Private Health Care Services unlimited examinations, checkups in numerous specialties free of charge
• Competitive salary and cafeteria
• 100% commuting allowance for non-Budapest residents

• Annual bonus
• Annual salary review
• Marriage and childbirth allowance
• School start allowance
• Loyalty award
• Employee Referral Program with remarkable referral bonus
• All You Can Move contract possibility/gym facility discount
• Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Fut u. 47, 1082)

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