Project Quality Engineer

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 ISO
14971

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 ISO
9001/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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