Quality Assurance Partner

Job Title : Quality Partner - Nonconformance & CAPA
Location : Remote
Hours : M-F EST Business Hours (Must have ability to work non-traditional work hours to accommodate a global team)
Compensation : $50.00 - $60.00/hr
Type : 12-month contract, Potential for extension or conversion to permanent

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 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
Required

• 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

• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.