Staff Supplier Quality Engineer

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Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function :

Supply Chain Engineering

Job Sub Function : Quality Engineering

Job Category :

Scientific / Technology

All Job Posting Locations :

Ringaskiddy, Cork, Ireland

Job Description :

SECTION 1 : JOB SUMMARY

The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.

The Staff Supplier Quality Engineer maintains the qualification of suppliers and their processes as well as lead activities associated with resolving complex technical issues that may require the development of new or improved techniques or procedures.

The position is the technical specialist able to make independent decisions on technical problems and methods, provide technical leadership and project management to qualify and improve supplier processes for the manufacture of medical devices.

SECTION 2 : DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :

Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned.

Perform and Support supplier / EM quality evaluations and / or audits, development of quality agreements, and other quality related activities impacting supplier.

Lead activities associated with resolving supplier quality issues.

This includes working with suppliers and internal partners to perform root cause analysis / failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.

Lead activities associated with supplier risk management.

This includes working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.

Lead activities associated with supplier process improvement.

This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices.

Provide Quality Engineering support to suppliers including assessments, inspection technique support, verification / validation activities, CAPA and change management.

FDA CFR Part 820 and ISO 13485 regulations / standards focus.

Champions compliance to validation regulations & standards (e.g. QSRs, ISO, EN and MDD / MDR) including providing support during internal and external audits.

Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).

Develop and report on supplier performance metrics.

Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.

Responsible for communicating business related issues or opportunities to next management level.

For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

SECTION 3 : EXPERIENCE AND EDUCATION

Bachelor\'s Degree is required; Master's Degree is preferred

Generally requires 4 – 6 years of work experience in a GMP and / or ISO regulated industry

Experience in the medical device / pharmaceutical industry is preferred

Engineering or science field of study is preferred

SECTION 4 : REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS / LICENSES and AFFILIATIONS

Excellent communication, teamwork, and problem-solving skills are required

Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions

Experience with machining, injection molding, metal processing such as passivation, anodizing and heat treating, and / or electronics assembly are preferred

FDA CFR and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.

Auditing background is a plus

Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred

Strong statistical analysis skills are preferred

Fluency in English is required

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