Quality Engineer

Sectors:
Information technology, telecommunications
Locations:
Republic of Ireland
Qualifications:
Not specified
Contract type:
Interim, contract & temporary
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
12/03/2019
Start Date:
ASAP
Recruiter:
Elevate Direct
Job Ref:
669058905

This role is ideal for someone who wants to progress their career collaborating across multiple functional areas and working closely with a highly dedicated and motivated team. You will be responsible for the evaluation, assessment, audit and audit follow up of supplier and commercial distributors audits for Johnson & Johnson Vision in EMEA.

What you're great at:

You will have wide Quality Engineering experience and be able to work effectively across many different functions internally and externally which will ensure that we meet both the customer and the business needs. You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player.

Continuous improvement will be at the heart of your decision making, looking for areas in which we can create efficiencies through better working practices to deliver enhanced compliance. You'll conduct day-to-day and strategic activities in supplier life cycle management, meaning you will be great at establishing clear expectations and collaborating with internal and external partners leading to consistent, reliable processes and services.

As a Quality Engineer, your typical day may include:

Execute and document non-conformances, Corrective Action Requests and Corrective and Preventive Actions and report on these metrics at Quality System management reviews. Define and lead actions related to change requests.

Lead and document internal audits for compliance to regulations, agreements, standards and documented processes, of market Companies and Distribution Centres.

Guide the development of and improve comprehensive measurement systems for quality performance.

Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects.

Lead and document internal quality procedure change efforts.

Provide guidance and leadership based on industry and process excellence standards at expert level, including good distribution practices (GDP), international organization for standardization (ISO) and country/governmental regulations (EU MDD/MDR and ISO 13485 regulations/standards will be the focus).

Participate in quality system improvement initiatives.

Act as CAPA Champion for the Region

Maintain the training curricula for the region.

Create Quality Management Reviews, in alignment with the business

Support the coordination of field actions and escalations

Qualifications and experience
* You will be Degree qualified, preferably a science degree, with experience of working in a regulated environment.
* 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 required.
* Exceptional communication skills to allow you to work effectively across various levels and teams
* A passion for continuous improvement
* Lead Auditor training
* It would also be preferred if you were knowledgeable in ISO and EU MDD/MDR regulations and have experience of Good Manufacturing Practice (GMP).

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

Closing Date:
09/04/2019
Contact Details:
Elevate Direct
Contact: Elevate Direct

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