Senior Quality Engineer

Cork  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Senior Quality Engineer - Cork, Ireland - €23 - €27 Per Hour - 12 Months

The Senior Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff. The Senior Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product life cycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.

Responsibilities & Duties

Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

Conduct benchmarking to develop more effective methods for improving quality

Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

Champions compliance to applicable Global Regulations and standards (eg QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.

Supports new product introduction as part of design transfer.

Lead and maintain Material Review Board.

Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification

Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans

Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan

Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes

Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Develop, interpret and implement standard and non-standard sampling plans

Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.

Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

Ensures effective quality strategies are created for the validation of test methods, process and design.

Qualifications and Experience

Bachelors Degree, preferably in Engineering or related technical field.

Experience working in both an FDA and European regulatory environment

This position will require relevant experience working in manufacturing/operations.

In-depth knowledge of product/process Risk Management (FDA and ISO standards)

Experience with a proven track record of implementing appropriate risk mitigation.

Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.

Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.

The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is highly desired.

Good technical understanding of manufacturing equipment and processes is required.

Understanding of the NPI (New Product Introduction) process and Process Validation expertise

A thorough understanding of GMP/ISO regulations and validation regulations

Demonstrated project management and project leadership abilities

Continuous Improvement Focus

Non Technical Skills and Additional Details

Experience in a regulated environment.

SIX SIGMA - Certification

Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)

Experience of the design and qualification documentation standards to current FDA expectations

Knowledge of statistical packages and Microsoft Office systems d.

Proven ability to review and critique Quality Critical technical documents.

A good understanding and working knowledge of FDA and ISO regulations.

Knowledge of lean manufacturing

Experience as Quality Engineer working in a cGMP environment preferably in medical device.

Positive attitude

Continuous Improvement orientation

Accepting of change

Flexible - Calmly reacts to the unexpected .

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Start date
ASAP
Duration
12 months
From
Elevate Direct
Published at
26.06.2018
Project ID:
1587706
Contract type
Freelance
To apply to this project you must log in.
Register