Responsibilities
To identify and implement key quality improvement opportunities across the
manufacturing operation working closely with production and engineering teams.
Assist Quality manager in establishing, implementing and maintaining the quality
management system.
Responsible for continual improvement activities to enhance the quality system, such
as 5S, Kaizen lean methods, etc.
Develop training to build quality awareness.
Interface with Engineering and Operations to ensure transfer to Production of new
products are in accordance with approved data.
To ensure that products and processes comply with the relevant requirements of the
quality management system.
Conduct audits, including closing out audit findings, creating audits finding reports
and determine proper corrective and preventive actions.
To control non conformance reports and ensure that effective root cause analysis and
CAPA are implemented.
Create and maintain company quality documentation, such as quality manuals,
quality procedures, etc.
Provide Quality Engineering support for operations in areas such as problem
analysis, process analysis and process improvements
Act as a project member, providing quality engineering and regulatory expertise in
support of product development projects or other projects
Advise on content and approve product & process validation protocols and reports
Maintaining Quality levels
Reliability engineering, defining reliability test programs
Essential Skills
Must be an effective communicator and a results orientated team player with a wide
technical knowledge
Must have proven problem anaylsis and problem solving skills
Must be trained in modern quality management techniques and auditing
Must have excellent computer skills (Including, but not limited to: Windows, Office,
Visio, Project Manager, and Internet).
Must be able to work independently, and proactively.
Must have experience in quality tools (FMEA, Control Plan, 8D, PPAP, DFSS, Lean,)
Must have good ISO9001quality system knowledge.
Must be an effective trainer/coach
Must be able to drive improvements and manage human change
Must have understanding of NPI processes
The Successful Candidate will be measured against the following KPI’s:
o Fall Off Rate reduced by 30%
o Fall Off Rate at launch of new products reduced by 30%
o Outgoing Quality Audit (faults that customers identify) reduced by 30% (customer
ppm)
o Cost of Non Quality
o Field Call Rate improvement in the assigned value streams – 10% reduction
Career Progression:
You can get great opportunities, challenging assignments and learning and
development programs to accelerate your opportunities for personal and professional growth.
A typical next step in the career for the successful candidate who has delivered against the
KPI’s for this role consistently will be to lead a sizeable operational quality activity after 3
years.
Additional Information:
Any knowledge of CFR820 or regulatory environments (such as FDA) will be considered
advantageous.
The two biggest challenges are:
o Change organization to use the (Lean) methodology as an enabler for
maturity within the plant.
o Achieve a fully compliant CFR820 plant.
The two biggest successes are:
o Achieving all the target metrics for customer PPM & Fall Off Rate
o Successfully passing all DMV, ETL, BRC and FDA external audits
