Quality Assurance Engineer
hace 3 días
Job Title: Ingeniero de Calidad I
Job Summary:
The Associate Engineer plays a key role in planning and supporting engineering projects or studies. This position applies engineering principles and practices within assigned areas, coordinating and directing technical support personnel. The quality engineer associate will utilize quality engineering tools and practices for effective and efficient development of transfers and product/process maintenance throughout the product life cycle. This individual will also utilize investigation and problem resolution skills to improve and maintain products/processes aligned with quality and global business vision. Risk management will be used to prevent unanticipated failure modes and improve process quality. This person will provide support to business processes.
Key Responsibilities:
- Under limited supervision, this position will:
- Business Improvement: Analyze the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques, and other improvement programs.
- Compliance / Regulatory: Ensure current products and processes comply with regulations, such as QSRs, ISO 13485, etc. Provide support during internal and external audits. Participate in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.). Respond to internal or external audit observations related to quality engineering. Establish and maintain required documentation of quality assurance activities and/or quality systems. Perform periodical audits of the line to evaluate GMPs, production controls, lot segregation, and process audit according to JJPS.
- Product Quality, Control, and Disposition and Performance Standards: Conduct or support investigations, bounding, documentation, revision, and approval of non-conformities (NCs), preventive and corrective actions (CAPAs), and customer complaints. Escalate quality problems when applicable. Support analysis of products related to customer complaints to determine failure modes. Responsible for identifying material, material segregation, classification of defect types, and successful application of these techniques in day-to-day manufacturing. Analyze/revise the effectiveness of preventive and corrective actions.
- Product Grading / Process: Revise, approve, execute IQ, OQ, PQ, TMV, or Software Validation. Maintain and periodically revise CTQs in the manufacturing process to guarantee continuous customer satisfaction. Provide support in revising and maintaining PEMEAs, Quality control plans, process instructions, and additional manufacturing documents. Develop, interpret, and properly implement process monitoring and control methods consistent with the process/product risk level. Evaluate and interpret common variation causes vs special in the manufacturing process and determine the adequacy of current process limits. Evaluate the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc. Determine the effectiveness of these techniques in previously implemented improvements. Responsible for risk assessment process including realization, documentation, revision, or maintenance of current risk and risk analysis documentation such as FMEA of the process given changes in the product/process.
- Strategic: Collaborate with other quality leaders to identify quality engineering abilities required and competences to allow execution of strategic vision.
- People: Provide supervision, mentoring, coaching, performance revision, development plans, and succession planning for others (when applicable). Responsible for communicating business-related issues or opportunities to next management level. For those who supervise or manage a staff, responsible for ensuring 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. Perform other duties assigned as needed.
Qualifications:
Experience and Education:
- Bachelor's in engineering: Mechanical, Electrical, Industrial, or applicable science.
- 0 to 2 years of work experience or demonstrated performance.
Required Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
- Use of computer packages.
- Ability to communicate in English, orally and in writing.
- Knowledge of engineering fundamentals.
- Knowledge of Product Risk Management/process (FDA and ISO regulations) is preferable.
- Ability to perform 'active involvement' in the solution of problems and resolution problems, preferable. Capacity to solve problems by providing good judgment, highly desired.
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