This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered signific... Visa mer
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
As a Quality Manager you ensure product quality through the implementation of various control and improvement opportunities and coordination of work within the area of Quality Management system, CAPA and Learning Management system. Support to Sr. QA Manager in ensuring that processes needed for the quality management system are established, implemented, and maintained. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
Essential Duties and Responsibilities
Management and further development of the QMS Team
Intelligently deploy resources to meet daily business needs in a timely manner while evolving the work processes to become more proactive, efficient, and effective
Provide strategic direction and leadership to the team to ensure operations adhere to requirements of compliance and product quality
Define and coordinate tasks within the scope of the objective and task definition, as well as review and discuss work results
Plan and execute local Audit program
Control and track the products and processes quality and regulatory compliance through adequate performance metrics and plans.
Stop, if required, the delivery and/or the production of products in case of non-conformity.
Ensure that adequate records of data and results concerning tests and product controls are taken
Manages effective cross-function relationships and in particular work with concept, product and commercialization teams to ensure quality of product and process.
Drive data analysis of performance data to identify high priority issues relating to safety, regulatory compliance and customer satisfaction.
Coordination of resources within area of Quality Management system, CAPA and Learning Management system
Continuous improvements of processes within area of responsibility
Implementation of the company-specific quality policy and quality goals
Ensuring product conformity, reducing production deviations
Ensuring compliance with design and development activities
Communication of the quality principles to promote quality awareness in the company
Ensuring compliance with production and process controls
Ensuring product conformity, reducing production deviations
Ensuring compliance with acceptance and validation activities
Management of non-compliant products and investigation of problems with regards to product quality, as well as support for processing: Carry out root cause analyzes, introduce corrective measures to eliminate or reduce the identified causes.
Serve as primary point of contact for quality and regulatory issues related to manufacturing processes
Lead efforts to identify and execute initiatives to improve manufacturing process and product quality
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
Proficient with Quality System Regulations, IS013485, Medical Device Regulation and ISO 13485 Quality System Standards.
Demonstrated ability to succeed in team environments and possesses effective interpersonal skills.
Demonstrated attention to detail, analytical decision-making, and problem-solving skills.
Proven ability to succeed in an environment of continuous improvement and to identify improvement opportunities.
Strong customer orientation and excellent written and verbal communication skills.
Ability to effectively navigate rapidly changing quality, regulatory and business environments and succeed in an environment of change.
Bachelor’s degree (minimum) in an Engineering field, preferable mechanical, electrical, or industrial engineering.
5+ years of experience in Quality Assurance or Regulatory Affairs in the Medical Device or Pharmaceutical industry.
Strong management and analytical skills
Strong process and continuous improvement skills
Supportive, positive attitude and approach to work
Good communication skills, both verbal and written
Able to work independently or as part of a team
Strategic skills, ability to holistic/global perspective
Additional training in Risk Management, Six Sigma, Lean Manufacturing and Statistical Methods is preferred.
Experience of an R&D and production site is a plus
Fluent in Swedish and English, other languages are beneficial
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