Quality Engineer II
Share
Job Location:
Newark, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Summary (List Format):
- Design implement and maintain quality assurance protocols and methods for processing materials into finished or partially finished products.
- Plan implement and manage compliance of manufacturing/production processes with internal and external safety quality and regulatory standards for worldwide distribution.
- Design methods and procedures for inspecting testing and evaluating the precision and accuracy of production processes equipment and finished products.
- Analyze reports and production data to identify trends and recommend updates or changes to quality standards and procedures.
- Ensure compliance with in-house and/or external specifications and standards (GLP GMP ISO Six Sigma).
- Resolve quality issues by performing root cause investigations risk assessments and implementing corrective and preventive actions (CAPA).
- Support and lead activities related to change orders process validations risk analysis and creation or major changes of SOPs/documents.
- Write and execute test method validations (TMVs) process qualifications (PQs) and simple change orders.
- Provide quality engineering support to Operations Engineering and R&D teams for medical device design and manufacturing.
- Develop and implement procedures inspection methods and test methods in compliance with QMS Medical Device Quality System Regulation and Device Directive requirements.
- Perform customer complaint investigations root cause analysis and corrective actions.
- Participate in facility and supplier audits and regulatory inspections (Notified Body FDA).
- Review and approve engineering change orders (ECOs) product-related documentation manufacturing procedures design process verifications and validation documentation.
- Prepare reports assessing the suitability and effectiveness of assigned areas of the quality system.
- Actively participate in meetings and processes such as MRB NCE CAPA and SCAR.
- Provide training on quality systems and procedures as needed.
- Stay abreast of technical developments by reviewing technical publications articles and abstracts.
- Ensure products meet regulatory and quality standards and customer expectations.
- Model quality values and coach others on quality system standards and best practices.
- May be required to work one Saturday per month and overtime.
- 100% onsite position; physical requirements include sitting standing walking lifting up to 40 lbs and working in environments with mechanical parts chemicals high voltage electronics radiation and clean rooms.
Qualifications:
- Technical Bachelors Degree required (Masters preferred).
- 1-2 years relevant experience with Bachelors Degree; 0-2 years with Masters Degree.
- Experience in an FDA-regulated industry is beneficial.
- Strong computer and technical writing skills.
- Knowledge of GMP GDP 21CFR820 ISO 13485 MDD requirements preferred.
- Beneficial: Knowledge in microbiology molecular biology chemistry nucleic acid technologies scientific method statistics Oracle Agile and Certified Quality Engineer.
- Excellent interpersonal and presentation skills.
Let me know if you need a shorter or more tailored version!
- Design implement and maintain quality assurance protocols and methods for processing materials into finished or partially finished products.
- Plan implement and manage compliance of manufacturing/production processes with internal and external safety quality and regulatory standards for worldwide distribution.
- Design methods and procedures for inspecting testing and evaluating the precision and accuracy of production processes equipment and finished products.
- Analyze reports and production data to identify trends and recommend updates or changes to quality standards and procedures.
- Ensure compliance with in-house and/or external specifications and standards (GLP GMP ISO Six Sigma).
- Resolve quality issues by performing root cause investigations risk assessments and implementing corrective and preventive actions (CAPA).
- Support and lead activities related to change orders process validations risk analysis and creation or major changes of SOPs/documents.
- Write and execute test method validations (TMVs) process qualifications (PQs) and simple change orders.
- Provide quality engineering support to Operations Engineering and R&D teams for medical device design and manufacturing.
- Develop and implement procedures inspection methods and test methods in compliance with QMS Medical Device Quality System Regulation and Device Directive requirements.
- Perform customer complaint investigations root cause analysis and corrective actions.
- Participate in facility and supplier audits and regulatory inspections (Notified Body FDA).
- Review and approve engineering change orders (ECOs) product-related documentation manufacturing procedures design process verifications and validation documentation.
- Prepare reports assessing the suitability and effectiveness of assigned areas of the quality system.
- Actively participate in meetings and processes such as MRB NCE CAPA and SCAR.
- Provide training on quality systems and procedures as needed.
- Stay abreast of technical developments by reviewing technical publications articles and abstracts.
- Ensure products meet regulatory and quality standards and customer expectations.
- Model quality values and coach others on quality system standards and best practices.
- May be required to work one Saturday per month and overtime.
- 100% onsite position; physical requirements include sitting standing walking lifting up to 40 lbs and working in environments with mechanical parts chemicals high voltage electronics radiation and clean rooms.
Qualifications:
- Technical Bachelors Degree required (Masters preferred).
- 1-2 years relevant experience with Bachelors Degree; 0-2 years with Masters Degree.
- Experience in an FDA-regulated industry is beneficial.
- Strong computer and technical writing skills.
- Knowledge of GMP GDP 21CFR820 ISO 13485 MDD requirements preferred.
- Beneficial: Knowledge in microbiology molecular biology chemistry nucleic acid technologies scientific method statistics Oracle Agile and Certified Quality Engineer.
- Excellent interpersonal and presentation skills.
Let me know if you need a shorter or more tailored version!
