This listing was posted on The Resumator.
Jr. NPI Quality Engineer
Location:
Manchester, NH
Description:
Merrimack Manufacturing is seeking an Jr. NPI Quality Engineer to support design transfer activities and quality operations in an innovative, fast-paced, medical device-manufacturing environment. This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to the organizational goals by leading improvement projects to increase efficiency and compliance across the site. How you will make an impact: Leverage your engineering and technical experience to evaluate new products, manufacturing processes and ensure compliance with applicable regulatory standards throughout the New Product Introduction process Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation Lead project teams through protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release for use Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills Lead the evaluation and identification of validation requirements and sampling plans for new, and changes to, manufacturing processes, test methods, and equipment Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing’s Quality Management System Participate in Material Review Board (MRB) meetings, track and follow through with nonconformance reports assigned Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers To be successful in this role, you will need the following skills and experience: Candidate must have a B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industry such as Aerospace, Military, etc. Strong knowledge of CFR Part 820 and ISO 13485 required Lean and Six Sigma certification strongly preferred Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications Knowledge of New Product Introduction processes and deliverables Strong knowledge of tolerance stack up calculations and calibration best practices Strong organization, communication, and time management skills; Project Management experience preferred Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred Powered by JazzHR
Company:
Merrimack Manufacturing
Posted:
February 22 on The Resumator
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to The Resumator
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Jr. NPI Quality Engineer
Jr. NPI Quality Engineer is a Quality Assurance Quality Engineer Job at Merrimack Manufacturing located in Manchester NH. Find other listings like Jr. NPI Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.
Jr. NPI Quality Engineer is a Quality Assurance Quality Engineer Job at Merrimack Manufacturing located in Manchester NH. Find other listings like Jr. NPI Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.