LCM Sr Quality Engineer

About MedTech 

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. 

We are searching for the best talent for LCM Sr Quality Engineer. 

JOB SUMMARY 

• Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers. 

DUTIES & RESPONSIBILITIES 

• In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 

• Primary responsibilities include working in Quality LCM or Quality Engineering and with other functional groups in support of new product/process development. 

• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. 

• Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction. 

• Develop and establish effective quality control and support associated risk management plans. 

• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders. 

• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). 

• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. 

• Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing. 

• Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans. 

• Support vendor audits as technical lead as needed and support Supplier Quality as Quality LCM representative as appropriate. 

• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. 

• Assist in complaint analysis as appropriate. 

• Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary. 

• Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. 

• Makes decisions independently on engineering problems and methods, and represents the organization in conferences to resolve important questions and to plan and coordinate work. 

• Consults with supervisor and provide guidance as needed concerning unusual problems and developments. 

• Responsible for one or more of the following as needed: 

• Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM activities. 

• In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a number of small projects with varying levels of complexity. 

• As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures. 

• Work is expected to result in the development of new or improved techniques or procedures. 

• Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods. 

• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable 

Additional Duties: 

• Responsible for communicating business related issues or opportunities to next management level 

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. 

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable 

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 

• Performs other duties assigned as needed 

EXPERIENCE AND EDUCATION 

• Bachelor’s degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master’s degree is preferred. 

• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. 

• Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable 

• Ability to develop and implement Quality standards. 

• Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices. 

• Thorough knowledge of leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies. 

• Ability to apply project management skills to ensure fulfillment of new product development requirements. 

• Demonstrated auditing and problem solving skills. 

• Understanding of Six Sigma and Process Excellence tools and methodologies. Lean manufacturing experience desirable. 

• Ability to train and mentor a diverse array of employees on quality topics. 

• Good understanding of theoretical and practical fundamentals and experimental engineering techniques. 

• May directly or indirectly manage QE, Technician, Inspector and other Quality positions below Sr. level within the Quality department. 

• This position will report to Staff QE level and above as defined by the Quality leadership of the department. 

• Potential internal interface may include Quality Engineering, Manufacturing/Operations, Supply Chain, Quality Systems, R&D, RA, Post-Market Surveillance, Clinical, Marketing, Technical Services, other organization departments and MD&D Sector groups 

• Up to 10% travel required (Domestic or International) 

• May interact with Suppliers and contract services in order to support functional role. 

• Will interact as needed with government agencies, Competent Authorities in process of supporting inspections, audits and/or inquiries related to products and processes.