Sr Quality System Specialist

Job Description Summary

As directed by the Senior Manager, Quality Systems, the Senior Quality Systems Specialist is accountable for support of the continued development, improvement, and implementation of the Quality System. This position actively participates in quality guidance and helps project & quality network teams for process improvement and continuous improvement activities.

Job Description

Position-specific responsibilities include support of the following, however are not limited to:

• Quality Systems (Franklin Lakes)
  • Maintains and improves the Franklin Lakes and WW Quality System, including key quality systems such as CAPA, Internal Audit, Supplier Management, Nonconformances, Analysis of Data, etc.
  • Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.
  • Develops training content and provides quality systems related training at unit and Plant locations
  • Performs Internal and Supplier audits
  • Participates in FDA, ISO, and other external audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.

• Quality Systems (Worldwide)
  • Support EU MDR Post Market Surveillance providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies.
    • Interface with other functions to ensure accurate and timely completion and review of documents.
    • Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices.
  • Actively participate in quality guidance and helps project & quality network teams for process improvement and continuous improvement activities
  • Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
  • Provide guidance and training to sites in various quality system areas such as CAPA, Internal audits, Supplier Management, Analysis of Quality Data, etc.
  • Supports quality system improvement and standardization initiatives within MDS

Skills and Knowledge:

• Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
• In-depth understanding of the application of quality systems to the medical device industry.
• Experience with Trackwise and SAP
• Advanced proficiency in data analysis tools such as Excel, Qlikview and BI report preferred.
• Excellent communication skills at all levels both written and verbal.
• Ability to set and deliver to specific goals and targets.
• Ability to perform multiple tasks and prioritize workload.
• Effective analytical, technical, and problem-solving skills.
• Effective meeting and presentation skills.
• Effectively manage conflict.
• Ability to work in or direct teams to obtain results.
• Self-motivated /directed.
• Ability to travel 10-15% (domestic and international)
• Typically requires a minimum of a Bachelor’s Degree (preferred Life Sciences or Engineering)
• Industry Recognized certification in a Quality System Element specialty  (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer) preferred
• A minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.