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The position will be responsible for providing quality engineering support. This position will work closely with R&D, Manufacturing in the design and manufacture of disposable medical catheters and console in compliance with applicable regulatory and statutory requirements.
- Conduct product returned investigations and ensure rapid resolution of product investigation and/or safety issues with cross functional group
- Support master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, and TMV
- Support approved Operations initiatives.
- Review and audit medical device records for comprehensiveness.
- Develop, review, and approve inspection plans and product drawings for new or modified product designs for quality characteristics
- Ensure that the contents of DMR and DHR are accurately developed and verified.
- Implement a risk-based approach to ensure product conformance with customer needs.
- Recommend and provide statistical support and expertise and analytical problem solving for product development and manufacturing.
- Lead the resolution of quality issues related to NCR and CAPA. Take appropriate actions to address the nonconformance of supplied goods and services.
- Develop activities that would drive prevention, detection of defects at earliest phase of product design.
- Assist in the investigation, root cause analysis, planning, and execution of activities within the CAPA system.
- Ensure robust final product testing is designed, developed, and implemented.
- Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc.
- Supports activities related to Management Review, audits (internal and external), deviations, CAPA, NCR, supplier management, RGA, and etc.
- Identify improvement opportunities related to the quality system and product
- Responsible for compliance with quality system procedures and all regulatory requirements.
- Other duties as assigned
Education:
Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
Required Experience:
Minimum 2 year (QE II) or 5 year (Senior QE) of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.
Knowledge, Skills, and Abilities:
Experience working in medical devices, while working within Quality is required.
GMP experience working within ISO 13485 and FDA 21 CFR Part 820 environments.
Capable of reviewing and interpreting drawings
- Experience in performing test method validation and Gage R&Rs is preferred
- In-depth understanding of statistical techniques such as normality analysis, tolerance analysis, and should be able to analyze and interpret data with high confidence.
- Must know how to use Minitab or other statistical software
Strong analytical, planning and organizational skills
Strong interpersonal and communications skills (oral & written)
Self-starter with ability to work independently under pressure and react quickly to changing priorities
Proficient in MS Office (Word, Excel, Power Point, Project, Visio)