Quality Engineer I
Quality Engineer I
Posted on :
30-04-2025
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1 Vacancy
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Job Description
Job Description:
- Reporting directly to the Quality Engineering Supervisor this position involves product team support for the manufacturing operations provides quality guidance product resolution decisions and statistical problemsolving techniques to manufacturing operations and projects teams for new product introduction process improvements continuous improvements and validation activities.
- This position works closely with other functions within the organization (Manufacturing R&D Continuous Improvement Quality Engineering Procurement and Marketing) and is responsible for the quality of the product and process for the assigned product line (s).
- Provide product team support including Material Review Board (MRB) customer complaint activities statistical analysis validation support inspection plans metrology quality metrics and report functions.
- Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires Certificates and Customer Surveys etc.
- Facilitates investigation of Nonconforming Process Report (NCPR) Situation Analysis (SA) and Health Hazar Evaluation (HHE) with clear documentation of corrective actions.
- Lead discussion on blocked stock and open notifications in Material Review Board (MRB..
- Assist with the investigation of Corrective & Preventive Actions (CAPA) nonconforming product and customer complaints providing solutions where possible.
- Communicate customer feedback to Quality Systems group.
- Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools FMEA CE Diagram DOE MSA Validation Protocol development review and approval and Control Plans.
- Support Continuous Improvement activities and key plant projects.
- Develop/Revise Quality Plans including incoming inprocess and final inspection and provide training to those affected by the plans.
- Implement proven inspection and metrology improvements and associated training.
- Review and approve Project Design History Files.
- Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO Standards.
- Serve as a resource for performing internal audits to ensure quality system compliance.
- Able to react to change and perform other duties as assigned.
- Bachelors degree in engineering.
- Minimum of 2 years of manufacturing quality engineering experience (preferably in a regulated industry such as health care medical device pharmaceutical etc..
- Good understanding of Continuous Improvement Methodologies including lean six sigma statistical applications and validation.
- ASQ Certified Quality Engineer.
- ASQ Certified Quality Auditor.
- Proficiency and/or working knowledge of databases and programs (i.e. SAP EtQ Access Excel Microsoft project Minitab..
- Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
- Ability to make decision regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplished assigned tasks.
- Knowledge of manufacturing processes and relevant statistical method for quality assurance i.e. capable of SixSigma skills certification preferred.
- Good understanding of Continuous Improvement Methodologies including lean six sigma statistical applications and validation.
- Proficiency in Minitab Microsoft Project word processing database and spreadsheet applications.
- Demonstrated technical writing skills.
- Thorough knowledge of the regulatory industry requirements ISO13485 ISO15378 Quality Management Systems Regulation CFR 21 part 820 GDP / cGMP.
- Standard business hours; Monday Friday. Flexibility required to accommodate interactions with all shifts within a 24/7 manufacturing operation.
- Up to 20 domestic and international.v
Employment Type
Full Time
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