Description
NextLink is a Swiss IT consultancy company that has been providing both IT services and IT staffing to major customers for the past 20 years.
NextLink is currently looking for a Senior Design Quality Engineer to work for a well-known pharma company based in Lyon area, France.
Starting Date: ASAP
Contract duration: 2 years
Work location: Lyon area, France
Job purpose:
Reporting to the Design Quality Engineering Manager the Senior Design Quality Engineer shall lead product development efforts and associated areas of activity.
The job holder will lead product development activities from a Technical Quality perspective by preparing appropriate Risk Management plans, reviewing Design Control plans and overseeing qualification & validation process with internal
manufacturing sites and/or external suppliers.
Principal Accountabilities:
- Risk Management oversight and review during DHF development and product life cycle phases. Driving the creation of an appropriate Risk Management Plan at the product concept phase and maintaining this plan to all phases.
- Deliver compliant transfers of Design History Files where required, ensuring transferred systems are understood and integrated into the Quality System.
- Supporting risk assessment activities: Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Support the product post market surveillance process from a technical Quality perspective.
- Review & report on analysis of field inquiry reports and support or lead in product Health Hazard Evaluations.
- Ensure effective problem analysis/complaint investigation (CAPA) as required and define through negotiation effective corrective actions.
- Develop effective Process Verification Strategies working with all product development cycle stakeholders.
- Provide reliability objectives & assessment plans for Product Development and sustaining team.
- Liaise with R&D to ensure CTQ (Critical To Quality) specifications are agreed and documented for all NPD.
- Lead Design for Inspection activities for all NPD to ensure latest technology is available to reduce Human factor. Lead QA input in Design for Manufacture activities.
- Produce quality process specifications as required during the development and implementation of new products. Approve design specifications (eg drawings, protocols) as defined for own scope of responsibility.
- Partner with affiliated disciplines (ie R&D, Regulatory Affairs, Clinical Affairs) work cross-functionally to ensure adequate design inputs are included in product development or change projects.
- Document and maintain in good order all relevant Quality documents.
- Working with relevant business stakeholders, support and lead in the Non-Conformance (NC), Corrective And Preventative Action (CAPA) investigations and general problem solving for both design and process.
- Provide statistical support for DOE (Design of Experiments), sampling plans, capability assessments, rationale development & hypothesis tests as required.
- Compile and execute validation protocols for new product/processes. Assist in resolving all quality issues, allowing transfer of manufacturing processes to Operations.
- Ensure consistency with other team QE's, site Quality Systems and corporate Quality Systems.
- Ensure compliance with all Documented Quality system, as per FDA QSR's and ISO requirements etc. during day to day activities.
- Assist the Quality Systems Manager and Compliance Manager to manage the regulatory compliance program to include FDA and BSI.
Qualifications, Experience and Special Aptitudes:
- A degree level or similar qualification in mechanical or industrial engineering.
- Creation and/or maintenance elements of Quality Systems.
- Minimum 5 years experience in a quality role within a regulated industry.
- Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
- Proven experience and training in Mechanical Engineering processes.
- Knowledge and understanding of validation techniques such as risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control and process verification.
- Full understanding and experience of internal audit administration, CAPA and operational/executive management review.
Must have a good understanding of Geometric Dimensioning and Tolerancing and be fully conversant with engineering drawings.
- Have the proven ability to interpret and create engineering specifications and procedures.
- Strong interpersonal skills.
- Must be PC literate, and familiar with MS Office applications
- Fluent English