Job Description
We are currently seeking a Sr. Quality Assurance Engineer for our Medical Device manufacturing client in Merrimack NH. This is a contract to hire opportunity.
Pay Rate: $55 to $60 Per Hour
Responsibilities:
Plan, devise and implement Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area to assure the highest quality levels and cost-effective compliance.
- Develop test techniques and procedures as required
- Assist in planning, devising and implementing Quality Assurance standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned project or area to assure the highest quality levels and cost effective compliance with contractual and company requirements.
- Apply basic engineering and scientific principles and techniques to assist in the development and establishment of quality assurance programs which provide and maintain the highest quality levels for an assigned project, product, or area
- Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of assigned products or production equipment
- Conduct experiments and audits to evaluate operating characteristics of products or processes
- Evaluate data from experiments and prepare reports and summaries outlining results and recommend revisions or modifications to the product or process to maintain or improve product quality
- Support customer and regulatory audits and assist in completing corrective actions to resolve any findings from audits
- Assist in evaluating the product’s producibility and reliability of the finished product, ensuring that all established standards and regulations are met
- Assist in determining equipment to be used to maximize manufacturing effectiveness and minimize cost
- Assist in complete failure analysis investigations to determine the root cause and take appropriate corrective action to revise design, methods and inspection/test instructions to prevent failure recurrence
- Evaluate and monitor the quality of vendor services and goods and recommend selection of optimum vendors
- Support the manufacturing process in resolving design problems, assist in the transition of products from development into production
- Review and assess Engineering Change Orders (ECOs) for design and process changes to ensure compliance with quality and regulatory requirements
- Collaborate with cross-functional teams to provide quality input for verification and validation activities
- Lead investigations, root cause analysis, and corrective action implementation to ensure timely closure of customer complaints
- Manage RMA process from product return through evaluation and disposition, driving trend analysis, and systemic issue resolution
- Monitor use of test equipment to ensure efficient utilization. Recommend corrective action related to design, application, or procedures
- Evaluate test specifications and test equipment for purposes of improving current methods and operations
Qualifications:
- A Bachelor's degree in a technical discipline and 2-4 years of related experiences to be proficient in the above areas; or an equivalent combination of education and experience
- Prior experience in Medical Device or Pharmaceutical manufacturing support
- FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971) is preferred
- Green Belt/Black Belt proficiency desired or CQE
- ISO 13485:2016 Lead auditor certification preferred
- Hands-on experience working with MES for production traceability
- Proficiency in PLM systems for managing change control and documentation
- Proficiency in data analytics tools such as Minitab, Tableau, Pow
Job Tags
Hourly pay, Contract work,