Represent Quality as part of a cross functional team to ensure
delivery of projects (NPI&#**Apply on the website**;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&#**Apply on the website**;s and ISO **Apply on
the website**/**Apply on the website** 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.
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
QUALIFICATIONS & EXPERIENCE
-A degree level or similar qualification in mechanical or industrial
engineering.
-Minimum 1 years 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.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment MAIN DUTIES & RESPONSIBILITIES:
Represent Quality as part of a cross functional team to ensure
delivery of projects (NPI&#**Apply on the website**;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&#**Apply on the website**;s and ISO **Apply on
the website**/**Apply on the website** 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.
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
QUALIFICATIONS & EXPERIENCE
-A degree level or similar qualification in mechanical or industrial
engineering.
-Minimum 1 years 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.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment
We need : English (Good)
Type: Permanent
Payment:
Category: Others
