HireDiversity

Skillman, NJ, US

Sr. Quality Engineer, Complaint Management (1 of 5)-2809120925

Description

Johnson & Johnson Consumer Products Company, a division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands Reach®, KY®, OB® and BAND-AID® Brand, as well as leading skin care brands such as Neutrogena® and Aveeno®.

The Sr. Quality Engineer, Complaint Management will process complaints within a timely and accurate manner. This position collaborates with internal and external sites to ensure timely closure of product complaints and must have proficient knowledge of products and their manufacturing process. The Sr. Quality Engineer, Complaint Management shall have strong analytical skills to quickly evaluate and categorize complaints and detect and analyze trends. They must be able to identify process issues and gaps and challenge the status quo in driving process improvement. The Sr. Quality Engineer, Complaint Management must have the ability to facilitate/coordinate various projects within the department, communicate effectively with all levels of management (internally & externally), and conduct training sessions with complaint systems.

The Sr. Quality Engineer will be expected to: Conduct and support complaint evaluations and escalation to appropiate staff/stakeholders. Conduct investigations and CAPA determination and implement CAPAs for complaints to be addressed by the Central QA organization.Categorize complaints for more regulated, complex products, and/or complex customer complaints. Provide risk-based QA Leadership support and independent decision making for a wide range of technical, compliance, and business issues with regard to complaint management activities. Support routine trending analysis activities and reporting as required. Analyze data and other trends, and present/report to senior management. Trend and/or review monthly complaints for possible escalation to CAPA. Generate and close failure investigation reports, and make timely decisions for reportable events by utilizing analytical and problem solving capabilities/tools. Use Quality Engineering principles, tools and practices to develop and optimize systems and processes in support of Central QA business objectives and building a center of excellence. Identify, initiate and support continuous process improvement efforts.Resolve and seek consensus across affected business areas.Organize and lead cross-functional team meetings to discuss issues related to complaint failures or investigations. Present data, conclusions and rationale to all stakeholders and external regulators as required. Support development/maintenance of complaint handling databases and procedures. Contribute to meeting organizational goals across the complaint life cycle as required. Provide direct guidance to less experienced staff during the evaluation and coding process.

Process and analyze product complaints according to Policies and Standard Operating Procedures. Evaluate complaints for seriousness (communicate timely, as appropriate), correct and consistent categorization, retrieval of field samples (US only), and investigation assignments. Ensure all relevant data to complaint is obtained. Collaborate with customers (manufacturing sites, Contact Centers, Medical Safety, Marketing, Sales Administration, etc) to gain knowledge of products and processes.

Audit Complaint Records in PQMS to ensure standard process is being followed, and complains are closed as required. Compile product and lot-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections.

Collaborate with internal and external sites to become familiar with product/manufacturing sites. Evaluate and assign complaints to sites/affiliates. Perform evaluation of field samples, close complaints as applicable, and enter investigations into the system from internal/external sites.

Qualifications


A minimum of a Bachelor's Degree in Science, Engineering, or related discipline OR equivalent job specific experience with a minimum of 5+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical or other related or highly regulated industry is required. Demonstrated knowledge and expertise in quality processes and regulatory requirements is required. Experience working in an FDA regulated environment is required. Experience supporting manufacturing, packaging, and development operations is preferred. Experience supporting many/all aspects of the complaint vigilance life cycle for medicinal, device, and /or cosmetic products is required. Device and medicinal strongly preferred.

Experience with one or more technologies supporting complaint handling is required. PQMS or similar system preferred. Experience in the creation, update, and management of complaint files from complaint identification through closure is required. Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA, and DMAIC is required. Experience with tools and techniques supporting qualitative risk analysis including but not limited to: Probability and impact assessment (likelihood of recurrence and potential effect), probability and impact matrix (risk ratings, rating rules), and risk categorization (by root causes, other qualifiers) is preferred. Experience with systems and tools supporting analysis and reporting is required.

Strong influence and negotiation skills and leading without direct line authority experience is required. Role must have demonstrated critical thinking, people and team development, strategic aptitude, independent leadership skills, and ability to interact with Regulatory Authorities. Excellent communications (verbal, written and listening) and collaboration skills - demonstrated through work products, presentations, accurate information gathering, and productive discussions/results. Strong knowledge of GMP Regulations, ICH and ISO guidelines including but not limited to: CFR parts 11, 210, 211, 820, and 803, ICH Q7, Q8 and Q9, and ISO 10002, 9001, 13485, and 14971 is preferred. Knowledge of FDA inspection guide for Quality Systems Inspections is preferred. This position will be based in Skillman, NJ and may require up to 10% travel.

Primary Location:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)