NPI Quality Engineer
Phillips-Medisize, Sligo is seeking a NPI Quality Engineer. This person will ensure the Quality Engineering Function is maintenance in line with Corporate Requirements, and in compliance at all times in supporting the compliant manufacture of products for our Customers.
Working within the Quality Group, the successful candidate must have the ability to work within the QMS with minimum supervision, understanding the entire QMS and how each and every process within the system integrates to achieve success at every stage. This person will be responsible for coordinating Quality Engineering related activity of new products introduced to the site specific to their area, as well as changes to existing products, equipment and processes.
S/he will be expected to contribute significantly to the future development and maintenance of the QMS.
- Work within a cross functional team involved in the setup, manufacturing and supply of products to our established customer base.
- Support the Quality Engineering elements of related processes, updating and improving the Quality Management System as required.
- Maintain the Quality Notification process for the management of CAPA, vendor CAPA, MRB, Customer Complaints, and similar related activities.
- Main strong relations with our customers to ensure all product specifications are clearly understood.
- Provide support to the areas of Validations, Metrology, Document Control, performing Internal Auditing.
- Provide input from a quality perspective to product & process risk assessments, pFMEA.
- Have overall responsibility for reporting on GMP compliance in working area, and at all times, promote same throughout the facility.
- Ensure environmental monitoring is performed and reported on in a timely manner.
- Liaise with other departments as required as part of day-to-day activities within the manufacturing environment, in particular Manufacturing Engineering, Production, Training.
- Lead the establishment of Quality Engineering activity associated with new products introduced to the site, to achieve a successful handover to the Operations Group post Validation.
- Work very close with the Validation Function within the site to ensure complete transparency and accuracy of validation & verification documentation generated in support of the new product introduction approval effort.
- Work cross functionally with all affected departments to ensure the quality engineering elements of the project are clearly understood, and team members clearly understand the requirements to be met.
- Work very closely with the sustaining quality engineering team to ensure they have had the opportunity to input into what will ultimately become their product and associated manufacturing process.
- Within project teams, support the following key areas:
- Initial Quality Assessment
- Vendor Selection, Assessment & Qualification, liaising directly with Vendors
- Validation Requirements
- Provide input from a quality perspective to product & process risk assessments, pFMEA
- Pilot Production & Product Approval
- Identification of ongoing Quality & Regulatory requirements
- As required, provide support to other Quality System & Engineering elements of the business.
- Ensure ongoing compliance, as applicable, with ISO13485 and other related Guidance Documents.
- Embrace the Corporate MBM (Market Based Management) Framework and Guiding Principles.
- Bachelor’s degree in Quality Management/ Quality Assurance / Engineering or equivalent industry experience
- 2 years’ experience in a similar role in the Medical Device Industry.
- Knowledge of ISO, MDD, FDA requirements essential.
- Knowledge of Quality Standards, Validation Regulations and Guidance Documents required
- MS Office proficient. Experience with SAP beneficial.
- Proven track record in a similar role.
- Strong project management capabilities.
- Excellent attention to detail in oral & written communication, with a proven technical protocol & report writing background
When you press “Apply now” you will be redirected to our Molex careers site. We process applications continuously. Please submit your CV soonest possible.
With your application you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies.
We are an equal opportunity employer.
bout Phillips-Medisize, LLC
Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.
To apply for this job please visit sjobs.brassring.com.