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Quality Systems Manager

, China

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Responsibilities

Location Jiangsu, JiangsuCN Job ID JR-026120

Quality Systems Manager

PerkinElmer Inc. is looking for a Manager of Quality Systems to join its global Quality Regulatory & Medical team. The primary responsibility for the Sr. Manager of Quality Systems is to provide Quality guidance and mentoring to the Global Quality Systems team and functional business partners. They will oversee the global complaint process as well as support the development and maintenance of PerkinElmer's Global Quality Management System.

Job Responsibilities

  • Support the Global Complaint Procedure, including regulatory complaints and ensure adequate investigation and closure.
  • Support the collaboration and execution of Global document changes including any document change request and training plan updates to LMS.
  • Manage a team of Quality Systems professionals and provide guidance on meeting quality objectives
  • Apply risk management skills and creative customer-focused solutions necessary to support the safety and effectiveness of our products and meet business objectives in a compliant and timely manner
  • Apply in-depth business knowledge to provide strategic methods and techniques to business goals and objectives.
  • Assure adherence to budgets, schedules, work plans, and performance requirements
  • Develop and foster strong relationships with key stakeholders within the facility and within broader PerkinElmer
  • Oversee execution within the Global Quality Management System
  • Collect, analyze, measure and monitor compliance and performance against objectives through Quality Management Review or Trend Review
  • Lead initiates on data analysis and reporting to Director of Quality Systems
  • Work on assigned projects, including corporate projects, with limited supervision
  • Actively participate in business review meetings as required

Required Experience

  • Bachelor’s degree in Life Sciences or equivalent work experience
  • 4+ years of experience in Quality Systems within the medical device or pharmaceutical industry or under an ISO13485:2016 QMS
  • 2-8 years of management experience.
  • Strong complaint investigation, adverse event reporting and CAPA skills
  • Strong data analysis skills and proficiency in electronic data management systems.
  • Must communicate fluently in English and Mandarin

Preferred Experience

  • Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners.
  • Exceptional attention to detail.
  • Ability to take direction and multi-task in a fast-paced environment.
  • Ability to manage and develop a diverse team skilled in complaint handling
  • Superior interpersonal, verbal and written communication skills.
  • Exceptional organizational, negotiation, and problem-solving skills

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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“PerkinElmer has empowered and provided me the opportunity to learn and grow with the company. Every success is celebrated at PerkinElmer. I contribute every success to my supportive mentors and my team, the best that I have got in my entire corporate years. The sense of belongingness and respect for each other gave me a deeper meaning of what a family truly means. At PerkinElmer, I have found my family.”

Cherylle Galapon, Sales Manager, Diagnostics, Philippines, KOSJ

“PerkinElmer is, by essence, a truly ethical company and I feel myself supported and valued. It is great to work in a place where my personal values match the company´s values, and that is PerkinElmer for me”

Michel dos Santos, Sr. Manager, Diagnostics, Brazil, LATAM

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