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Quality Assurance Specialist

Hybrid - Piscataway, NJ

Role Description:

The QA Specialist is responsible for managing processes such as (Document Control and Corrective Action and Preventive Action) and conducting quality assurance auditsof the quality management system to ensure compliance with ISO 13485:2016 standard and applicable regulatory requirements.

Essential Duties and Responsibilities:

· Participates in preparation for and hosting of external audits and FDA inspections in collaboration with the Sr. VP Regulatory Affairs.

· Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.

· Assists in the preparation of periodic Management Review meetings which are held to meet regulatory requirements.

· Stay current with new or potential business opportunities and prepare for all QA activities.

· Manage the POD (Point of Distribution) labeling process for OUS labeling requirements.

· Ensures that the Document Control System is maintained including SOPs, methods, production records, change controls, deviations, validation documents, operation manuals, training documents and any other relevant controlled documents in compliance with cGMPs, and international policies and procedures.

· Maintains and helps improve current quality systems, processes, tools, policies, SOPs and validations to ensure compliance with regulatory requirements.

· Assists with recording and provides regulatory reportability decisions on complaints.

· Assists with generating and submitting medical device event reports to appropriate authorities and government agencies as requested and as required by applicable laws and regulations.

· Manages the Corrective Action and Preventive Action process and the Non-Conforming Material process. · Performs root cause investigations and is involved in CAPA (Corrective and Preventive Action) activities. · Collects CAPA data and process metrics to capture and generate trend reports. · Review and approve batch production records for accuracy, completeness, and compliance with established procedures. · Analyze sterilization reports and validation data to ensure sterility assurance levels meet regulatory requirements

Skills and Competencies:

· Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

· Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

· Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

· Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

· Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

· Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learningand building new capabilities into self

· Problem Solving & Problem Prevention: Learns and uses strong problem-solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

· Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

Role Qualifications (Education & Experience):

· Bachelor’s degree in technical, scientific, or business-related discipline preferred.

· 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above.

· Knowledge of medical terms and Medical Device Reporting regulations

· Exceptional organizational skills and attention to detail.

· Able to perform job function with minimal supervision and work independently, taking initiative to make independent decisions, where appropriate.

 

Physical Demands (if any) as well as how much travel the job requires:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable

accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job:

· Work safely and follow all OSHA regulations and company safety policies and procedures.

· For all on-the-job injuries or accidents, must notify manager/supervisor immediately.

· Ability to regularly sit or stand for extended periods of time.

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