Title:  Manager, Quality Assurance

Job Summary

• This position will lead the Quality Systems team within the Quality Assurance group at the Jersey Shore site.
• This role is responsible for the management of the team and the coordination of all activities.
• Focus is to drive quality improvement activities in operations by executing quality improvement projects, providing relevant data and data analysis as well as supporting customer complaints, customer audits, changer controls, CAPAs and operation and engineering led improvement activities.
• The team will launch or support the publication of relevant quality reports like APRs or monitoring reports. All relevant activities around GMP compliance also fall into the responsibilities of the team.

Essential Duties and Responsibilities

• Site QA Manager designee for QA Systems and customer engagement activities.
• Manages Customer Complaint investigations and reporting to ensure adherence to global policies
• Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints.
• Ensure that identified CAPA’s are implemented on time and able to effectively address the root causes of the issues.
• Ensure that identified Change Control’s are implemented on time and able to effectively.
• Manage cross functional teams to drive product quality improvement projects.
• Ensures compliance with Customer Agreements and Specifications, Applicable ISO standards and regulations.
• Manage the quality systems group to maintain ISO 15378 / 9001 compliance.
• Ensure data integrity of data generated in or housed within the quaiity systems. Take actions in case of gap identified in terms of data integrity.
• Participate in technology transfer activities including risk assessment, equivalency studies and part number setup.
• Support validation of facilities and equipment and process.  Approve engineering studies and other protocols as required.
• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
• Manages and support Customer and Corporate Audits.
• Manage and support post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
• Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations.
• Generate, review, or approve Quality Assurance related documentation required for product.
• Other duties as assigned.

Education

• Bachelor’s degree in science or engineering or related technical discipline required.  Consideration of relavant work experience with associates degree.

Work Experience

• Minimum 5 years management experience required preferably in a quality role.

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Experience Able to comply with the company’s safety policy at all times
• In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
• Experience with SAP systems
• Familiarity with document management databases, particularly MasterControl
• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Able to comply with the company’s quality policy at all times.

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification preferred

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.