Project Quality Engineer

The Position : Product QualityEngineer

This role will workcooperatively with crossfunctional teams to deliver innovativeBattery Diagnostic Management solution and applications.

Throughthe application of established design control process this rolewill provide Product Quality Engineering support for thecommercialization of the companys products and will requireextensive interaction and collaboration with internal departmentsand external suppliers.

ESSENTIALDUTIES ANDRESPONSIBILITIES :

• Provideeffective product quality technical support toengineering supply chain production andQA
• Plan Execute and manage the Product qualityplan
• Lead andmanage the product Risk Management file compliantwith ISO14971
• Lead andmanage Product FAIprocess
• Lead Manage andparticipate in development of product qualitycontrol plans
• Participate andsupport the development of componentspecification
• Track andimprove engineeringKPI
• Assure supplieracceptance and understanding of quality andspecification requirements
• Manageand maintain engineering equipment andassets
• Lead engineering QRB meeting engagecross functional team members asrequired

EducationandExperience :

• Bachelorsdegree in Lifesciences / Engineering or equivalentexperience
• 38 years ofexperience in product engineering for marketedproducts spanning the full product life cycle : R&D NPI andsustaining engineering
• Experiencein product development within a quality system thatmeets FDA CE and other regulatorystandards
• Experience working in aISO9001 / ISO 13485 and cGMP environment designdocumentation risk management verification andvalidation
• Knowledge andexperience of obtaining and maintaining IEC 606011ed. 3.1 certification
• Experienceperforming risk assessments and FMEA according toISO 14971
• Demonstrated leadershipability
• Proficientplanning scheduling and organizingskills
• Strong troubleshooting andproblemsolving skills including rootcause analysis(5 Whys Fishbone etc)
• ExcellentEnglish verbal and written communicationskills

Local CandidatesPreferred.

We thank everyone for their intrest inour company. However only shortlisted Candidates will becontacted.

Job Types : FulltimePermanent

Salary : From $67000.00 peryear

Supplemental paytypes :

Bonuspay

Education :

BachelorsDegree(preferred)

Experience :

Productdevelopment : 3 years(preferred)

Language :

English(required)

Ability toCommute :

WorkLocation : In person

ClosingDate : April 30th 2024

Remote Work :