Job opportunity
Project Quality Engineer
All industrial jobs
This role will work cooperatively with cross-functional teams to deliver innovative, Battery Diagnostic Management solution and applications. Through the application of established design control process this role will provide Product Quality Engineering support for the commercialization of the companys products and will require extensive interaction and collaboration with internal departments and external suppliers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide effective
product quality technical support to engineering, supply chain, production and QA
Plan, Execute, and manage
the Product quality plan
Lead and manage
the product Risk Management file compliant with ISO14971
Lead and manage
Product FAI process
Lead, Manage and participate
in development of product quality control plans
Participate and support
the development of component specification
Track and improve
engineering KPI
Assure supplier acceptance
and understanding of quality and specification requirements
Manage and maintain
engineering equipment and assets
Lead engineering QRB meeting, engage cross functional team members as required
Education and Experience
Bachelors degree
in Life-sciences/Engineering or equivalent experience
3-8 years of experience
in product engineering for marketed products, spanning the full product life cycle: R&D, NPI, and sustaining engineering
Experience in product development
within a quality system that meets FDA, CE and other regulatory standards
Experience working in a ISO9001/ISO 13485
and cGMP environment, design documentation, risk management, verification and validation
Knowledge and experience
of obtaining and maintaining IEC 60601-1 ed. 3.1 certification
Experience performing risk assessments
and FMEA according to ISO 14971
Demonstrated
leadership ability
Proficient planning , scheduling, and organizing skills
Strong troubleshooting and problem-solving skills
including root-cause analysis (5 Whys, Fishbone, etc)
Excellent English
verbal and written communication skills
Local Candidates Preferred.
We thank everyone for their intrest in our company. However, only shortlisted Candidates will be contacted.
Job Types: Full-time, Permanent
Salary: From $67,000.00 per year
Supplemental pay types
Dental care
Extended health care
Life insurance
Paid time off
Schedule
8 hour shift
Day shift
Monday to Friday
Education
Bachelor's Degree (preferred)
Experience
Product development: 3 years (preferred)
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Apply on source site ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide effective
product quality technical support to engineering, supply chain, production and QA
Plan, Execute, and manage
the Product quality plan
Lead and manage
the product Risk Management file compliant with ISO14971
Lead and manage
Product FAI process
Lead, Manage and participate
in development of product quality control plans
Participate and support
the development of component specification
Track and improve
engineering KPI
Assure supplier acceptance
and understanding of quality and specification requirements
Manage and maintain
engineering equipment and assets
Lead engineering QRB meeting, engage cross functional team members as required
Education and Experience
Bachelors degree
in Life-sciences/Engineering or equivalent experience
3-8 years of experience
in product engineering for marketed products, spanning the full product life cycle: R&D, NPI, and sustaining engineering
Experience in product development
within a quality system that meets FDA, CE and other regulatory standards
Experience working in a ISO9001/ISO 13485
and cGMP environment, design documentation, risk management, verification and validation
Knowledge and experience
of obtaining and maintaining IEC 60601-1 ed. 3.1 certification
Experience performing risk assessments
and FMEA according to ISO 14971
Demonstrated
leadership ability
Proficient planning , scheduling, and organizing skills
Strong troubleshooting and problem-solving skills
including root-cause analysis (5 Whys, Fishbone, etc)
Excellent English
verbal and written communication skills
Local Candidates Preferred.
We thank everyone for their intrest in our company. However, only shortlisted Candidates will be contacted.
Job Types: Full-time, Permanent
Salary: From $67,000.00 per year
Supplemental pay types
Dental care
Extended health care
Life insurance
Paid time off
Schedule
8 hour shift
Day shift
Monday to Friday
Education
Bachelor's Degree (preferred)
Experience
Product development: 3 years (preferred)
#J-18808-Ljbffr