Senior Quality Assurance Specialist
2 weken geleden
As a Senior Quality Engineer, you will collaborate with Quality Management to recommend, design, and implement functional process improvements. You will develop, establish, and maintain quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. This role requires a strong commitment to patient safety and product quality, ensuring compliance with the Quality Policy and all documented quality processes and procedures.
Your Responsibilities:- Proactively demonstrate leadership and seniority in implementing all Quality standards and procedures in operational processes, ensuring compliance with Corporate and Regulatory requirements.
- Implement Quality standards and procedures in operational processes, ensuring compliance with Corporate and Regulatory requirements.
- Represent the business user by working closely with stakeholders to translate User Requirements into Business User Stories and Acceptance Criteria.
- Analyze and translate User Requirements, assessing options before arriving at a solution to improve current systems and increase productivity.
- Coordinate User Requirements, aligning with Testing Scenarios, creating test cases, and executing test cases to support the Testing Phase and network-wide Deployment.
- Liaise with the Training team and Site Super Users/Business Process Leads/Subject Matter Experts to support training plans for key Applications, enhancing the knowledge base across quality and D&L workstream.
- Proactively influence functionally and regionally in areas of new concepts, adoption of Best Practices, and process improvements.
- Coordinate and liaise with other Magellan Workstreams, Business Process Leads, SMEs, Communities of Practice, IT Solution Architects/COE, and Stakeholders to develop a strong and deep pool of expertise across Service to Cash.
- Collaborate with the broader Magellan Workstreams, IT Solution Architects/COE, and other Magellan Workstreams in a Scalable Agile Framework/DevOps methodology to enable rapid deployment.
- Work with team members and stakeholders to analyze the impact of system changes and develop remediation plans for risks raised.
- Support the preparation and gathering of documentation and testing of new system functionalities.
- Proactively investigate, identify, and implement best-in-class Quality Engineering practices and manage improvement projects within the organization (VIP, QMP, Star, Lean, 5S).
- Perform general QA-related activities.
- Support and prepare for site-level internal and external audits and act as a Subject Matter Expert (SME) in audits.
- 5+ years' experience with a Bachelor's Degree or equivalent in a manufacturing environment.
- 2+ years of Systems/Applications experience in SAP; Business Process Leads/Subject Matter Experts.
- Working knowledge of ERP systems combined with knowledge of key business processes.
- Comprehensive understanding of the MDD/EU MDR, ISO standards, and cGMP.
- Effective team member, fully motivated to achieve and demonstrate best practices in line with the department and global objectives.
- Good social and communication skills.
- Strong analytical skills, eager to improve and results-oriented.
- Good knowledge of the English language (verbal and written).
- Medical device industry experience.
- Working knowledge of SAP S4Hana service management and/or quality processes, covering data management.
- Gathering, analyzing, and interpreting data to understand gaps and risk assessment.
- Previous experience of a major program introduction/upgrade, ideally within an IT/Systems or Business representative role.
- Sense of urgency and commitment to execution.
As a leader in medical science for over 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
We are a global business and a global corporate citizen, and we have a responsibility to apply those values to everything we do. If you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
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