Quality Assurance Partner

Responsibilities

• Drive business results and customer value by performing activities as required to meet Q&R goals and objectives independently.
• Identify improvements and implement them through collaboration with your manager.
• Act as a coach for colleagues with less experience and help develop skills/expertise.
• Document authoring and review as required to support changes and perform technical reviews, as applicable.
• Prepare documentation for and participate in audits as applicable.
• Troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
• Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
• Advance the work of the Networks, making tradeoffs and breaking silos.
• Initiate activities independently and initiate interactions across departments as applicable.
• Empower and enable the Networks by maintaining strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities.
• Build a culture of continuous improvement.
• Enable the organizations New Ways of Working and act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in Diagnostics Operating Principles.

Qualifications

• Bachelors or Master degree in Life Science, Data Science or related subject, or equivalent experience
• 3-5 years of experience managing nonconformances and CAPAs within the medical device, biotechnology, or pharmaceutical sectors.
• Experience with instrumentation or reagent products is a plus.
• Proven ability to influence stakeholders, build collaborative partnerships, and cultivate strong professional relationships through exceptional communication.
• Demonstrated versatility across multiple quality management functions, with experience working both within and outside of the Quality department.
• Previous experience managing highly complex and/or global projects.

Preferred Qualifications

• Experience in a role outside of quality (operations, development, engineering or related)
• Working knowledge of SAP; Smartsheets; Tableau; Trello; Master Control; eTQ; Veeva; Monday.com; AI tools (as they relate to quality systems)
• Experience working in global teams, on projects or/and environments.