Engineering, Quality and VALidation (EQVAL) Consulting Group Hiring for Supplier Quality Engineer at Ponce, PR Full Time

Supplier Quality Engineer

EQVAL Consulting Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

The Supplier Quality Engineer must have experience with packaging and validations procedures in Pharmaceutical and Medical Devices manufacturing environments.

Minimum Requirements:

• Bachelor’s Degree in Engineer
• Experience 3 – 5 years
• Bilingual (Spanish and English)
• Experience in Packaging & Validations
• Experience with EUMDR Regulations
• Strong communication skills (oral and written)
• Knowledge in: Process Validation, Computer Software Validation and Investigation and root cause analysis skills.

Job Descrpition:

• Ensure that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards .
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Experience with EUMDR regulation and the changes needed in medical devices to be compliant with new regulations.
• Function on deliverable needed to remediate products to EUMDR and provide guidance to other cross functional team members from Quality function point of view.
• Interpret guidance documents and ISO Standards and apply them to EUMDR remediation.
• Broad understanding of how medical devices are approved in the European Union such as interaction with Notified Body’s, Quality system requirements.
• Ability to quickly come up to speed with other changing medical device regulations in the Europe region.

Job Types: Full-time, Contract

Pay: From $65,000.00 per year

Benefits:

• Dental insurance
• Employee assistance program
• Health insurance
• Referral program
• Relocation assistance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekend availability

Work Location: In person