Quality Partner - Nonconformance & CAPA

About the role

You drive business results and customer value by performing activities as required to meet Q&R goals and objectives independently. You are able to identify improvements and implement them through collaboration with your manager. You act as a coach for colleagues with less experience and help develop skills/expertise. You document authoring and review as required to support changes and perform technical reviews, as applicable. This may require collaboration with a supervisor on technically complex technical reviews. You prepare documentation for and participate in audits as applicable. You are able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance. You communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management. You advance the work of the Networks, making tradeoffs and breaking silos. You 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. You build a culture of continuous improvement. You enable the organization’s 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.

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.
• This may require collaboration with a supervisor on technically complex technical reviews.
• 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 organization’s 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.

Requirements

• Bachelor’s 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

Qualifications

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

Skills

• 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
• Working knowledge of SAP; Smartsheets; Tableau; Trello; Master Control; eTQ; VIVA; Monday.com; AI tools (as they relate to quality systems)
• You have worked in global teams, on projects or/and environments.

Benefits

Pay ranges between 50-60/hr based on experience