Quality Engineer

DIRECT CANDIDATES ONLY WILL BE ACCEPTED, IF INTERESTED APPLY THROUGH JOB POST. NO DM PLEASE.

RECRUITING FIRMS : DO NOT CONTACT THE POSTER OR ANY MEMBER OF THE HIRING COMPANY.

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)