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 workplace, 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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