Title:  Manager Quality Assurance, Integrated Systems

What We Offer

Job Summary

The primary responsibilities of the Customer Quality Manager, Integrated Systems, involve over-sight of the Quality Management System (QMS), Customer Quality issues, questions / concerns, Customer facing related items and audits as well as overseeing supplier performance metrics and support / drive supplier audits, out of specification (OOS) investigations. Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues. Partners closely with internal stakeholders i.e Operations, Technical Customer Support, Sales, Labs, R&D, and Product Management to ensure that customer quality issues are resolved in a timely manner and the needs of the customer are being met. Maintaining and reporting metrics and  trends to Senior Management and Extended Leadership Team (ELT) and implementing improvements on a continuous and pro-active basis. Generate, manage and oversee customer and supplier quality agreements Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. Reports directly to the Snr Quality Engineering Manager.

Essential Duties and Responsibilities

• System Owner of the Integrated Systems (IS) Quality Management System (QMS)
• Hosting of third-party audits, control room set-up and management of general audit readiness throughout the business.
• Post Audit follow-up and reporting both internally & externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactorily.
• Coordinate the monthly Quality Systems KPI reporting activity both internally and to corporate level.Support customer regulatory submissions as required.Interface with other departments on a regular basis to ensure adherence to IS QMS, drive quality improvements and compile/relay trends and occurrences throughout the year.
• To coordinate and support complaint handling of product complaints received by customer
• Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
• To open, track and maintain records for complaints received by customers.
• Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
• Generate and maintain quality metrics for reporting to ELT
• Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
• Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
• Participate in or lead customer review meetings
• Create and maintain customer quality dashboard
• Perform trending of customer quality dashboard based on customer data
  Main point of contact for customer regarding complaints, queries, change notifications, minor, major and critical change notification analysis and audits
• Co-ordinate internal resources, timelines and activities to drive resolution of customer OOS and non OOS quality issues
• Co-ordinate internal and external communications related to customer issues (OOS and Non OOS)
• Work with customer and internal stakeholders to create customer quality plans where applicable
• Generate, manage and oversee customer and supplier quality agreements
• Keep current with the industry standard practices and relevant regulatory requirements
• Perform additional duties at the request of the direct supervisor.

Basic Qualifications

• BA/BSE in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience. 
• Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment.
• A thorough working knowledge of quality systems such as ISO 15378 /ISO 13485 / 21 CFR Part 820 / EU GMP is essential.
• Accredited lead auditor against recognized quality standards in support of audits
• Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
• Experience of hosting regulatory audits from either the European or US authorities
• Must have excellent communication and written skills
• Must be able to work in a fast paced environment.
• Must be able to travel as required by the position.
• Must be able to organize and prioritize tasks, problem solve, must be detail orientated and self-motivated.
• Must be able to work independently on own projects while working concurrently with all departments

Preferred Knowledge, Skills and Abilities

• Knowledge of and experience in setting up and maintaining an effective QMS.
• An ability to collaborate across functional roles and work effectively in a team environment
• Knowledge of GMP requirements
• Customer facing experience
• Project management experience
• Strong project management skills
• Previous experience with MasterControl, SAP, SharePoint, Teamcenter #LI-NJ1 #LI-Hybrid

License and Certifications

• Engineering - Development\Certified Software Quality Engineer (ASQ CSQE) preferred
• Manufacturing\Six Sigma Green Belt Certification

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with suppliers.