*job function*:
quality
*job sub function*:
quality assurance
*job category*:
professional
*all job posting locations*:
ciudad juarez, chihuahua, mexico
fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
*we are searching for the best talent for sr quality engineer to be in juarez city.*
*you will be responsible for*:
- primary responsibilities include working in quality engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.
- 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.
- 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 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.
*qualifications / requirements*:
- 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.
- demonstrated auditing and problem-solving skills.
- understanding of six sigma and business 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.
*required skills*:
*preferred skills*:
business alignment, business behavior, coaching, compliance management, continuous improvement, data analysis, detail-oriented, goal attainment, human-centered design, internal controls, issue escalation, problem solving, process oriented, quality control (qc), quality management systems (qms), quality standards