Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Ensures that suppliers deliver quality parts, materials, and services.
• 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.
• Understanding and / or experience with EUMDR regulation and the changes needed in medical devices to be compliant with new regulation.
• Act as Voice of Quality function on deliverables 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 European Union such as interactions with Notified Body’s, Quality system requirements.
• Existing familiarity or ability to quickly come up to speed with other changing medical device regulations in the Europe region.

Qualifications:

• Bachelor’s degree in engineering
• Practical knowledge in Packaging, Validations and Regulations as EUMDR and ISO Standards.
• Three (3) years of relevant experience
• Investigation and root cause analysis skills
• Technical writing knowledge.
• Organization and Communication skills
• Process Validation and Computer software validation knowledge
• Bilingual (Spanish, English)
• Quality experience
• Availability for 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Job Types: Full-time, Temporary

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Ponce, PR: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 1 year (Preferred)
• Component Qualifications: 1 year (Required)
• Quality audits: 1 year (Required)

Language:

• English (Preferred)

Work Location: In person

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