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Quality Assurance Engineer
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Job Summary:
The Associate Engineer plays a key role in supporting engineering projects and studies, applying engineering principles and practices to assigned areas. This position involves coordinating and directing technical support activities, as well as being responsible for the technical development of assigned personnel. The Quality Engineer Associate will utilize quality engineering tools and practices to ensure the 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. Additionally, they will apply risk management techniques to prevent unanticipated failure modes and improve process quality. This role provides support to business processes.
Duties and Responsibilities:
- Review and analyze the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques, and other improvement programs.
- Verify that current products and processes comply with regulations, such as QSRs, ISO 13485, etc., and 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 the function of quality engineering.
- Maintain required documentation of quality assurance activities and/or quality systems.
- Perform periodic audits of the line to evaluate GMPs, production controls, lot segregation, and process audit according to JJPS. Verify that corrective and preventive actions are adequate.
- 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 and revise the effectiveness of preventive and corrective actions.
- Review, approve, execute IQ, OQ, PQ, TMV, or Software Validation.
- Maintain and periodically revise CTQs in the manufacturing process to ensure continuous customer satisfaction.
- Provide support in revising and maintaining PEMEAs, Quality Control Plans, process instructions, and additional manufacturing documents.
- Develop, interpret, and implement process monitoring and control methods consistent with process/product risk levels.
- Evaluate and interpret common variation causes vs. special causes in the manufacturing process and determine the adequacy of current process limits.
- Evaluate the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, risk to the patient, process capacity, process control, etc.
- Determine the effectiveness of these techniques in previously implemented improvements.
- Responsible for the 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.
- Collaborate with other quality leaders to identify quality engineering abilities required and competences to allow execution of the strategic vision.
- Provide supervision, mentoring, coaching, performance revision, development plans, and succession planning for others (when applicable).
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 problem-solving and resolution, preferable. Capacity to solve problems by providing good judgment, highly desired.
