Quality Engineer

Job description

DePuy Synthes are now recruiting for a Quality Engineer to join the team, this is an innovative, dynamic, forward thinking, results oriented team based onsite in DePuy Synthes Cork, this role will report into the Quality Engineering Leader.

JOB PURPOSE:

Reporting to the QE Leader Leader the Quality Engineer shall lead from a Quality perspective.

The job holder will lead the QA element of process / technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and DePuy R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

ORGANISATIONAL INTERFACES:

• All DePuy World Wide facility Quality, Operational and R&D.

• DePuy Vendor management personnel.

MAIN DUTIES & RESPONSIBILITIES:

Represent Quality as part of a cross functional team to ensure delivery of projects (NPI's and Technology) into production with the highest level of quality, compliance, and adherence to timelines

Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.

Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production

Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.

Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development

Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.

Lead QA input to Design for Manufacture activities on site.

Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR's and ISO 13485/9001 requirements etc. during all day to day

Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.

Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.

Assist in the development, review and approve product, gauge, tooling and fixturing drawings.

Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.

TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE CSOP MANUAL

KEY COMPETENCIES REQUIRED

• Culturally aware

• Flexible

• Team player

• Good influencing skills

• Project Management skills

• Good generalist (experienced quality person)

• Methodical

• Defuser, not inflamer

• Good communicator

• Politically sensitive

• Travel Flexibility

Desired profile

QUALIFICATIONS & EXPERIENCE

-A degree level or similar qualification in mechanical or industrial engineering.

-Minimum 1 year's 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.