Title: Quality Engineering Specialist - 60806 (Añasco)
Job Type: Professional services contract.
Duration: Depends on project schedule
Where: Añasco, On-Site
Hour Rate: Depends on the expertise. Negotiable
MINIMUM QUALIFICATIONS
Education and/or experience:
- BS in Mechanical Engineering, Industrial Engineering, Chemical Engineering or related science.
- Experience in the medical device and/or pharmaceutical manufacturing environment; on a Quality Engineer position.
- Experience in Facilities, HVAC, Clean Room, CSV (from IQ to EMPQ).
- Experience writing and revising controlled procedures, and validation protocols.
- Experience supporting Quality Management Systems.
- Experience with Change Control, Deviation Management.
- Experience with QMS remediation projects.
- Experience implementing ISO 13485 Quality System.
Responsibilities:
- Responsible for supporting and executing the Quality Management System (QMS) Remediation Plan in compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), EU MDR 2017/745, applicable regulatory requirements, and company procedures.
Qualifications:
- Knowledge of FDA, OSHA, and GMP's and ISO requirements.
- Must have a thorough understanding of verification and validation processes.
- Must have excellent communication skills and a strong track record of working cross-functionally.
- Experience with managing documents within electronic PLM system.
- Must have demonstrated ability to think strategically.
- Must be able to develop technical documentation.
- Teamwork oriented and self-starter.
Other Requirements:
- Excellent interpersonal and communication skills at all levels.
- Fully bilingual (English and Spanish).
- Must speak Spanish fluently (native).
- Teamwork oriented and self-starter.
- Need to have full attention to details.
- Skills in working under time pressure.
- Availability to work extended hours in a day and weekends if required.
- Available to start as soon as possible.
- Must live in Puerto Rico. No relocation nor travel expenses available.
- Resumes must be in English.
- We seek experienced professionals; no training will be given on the position requirements.
- Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. No C2C available.
- Are you a match? Please apply to Indeed position OR send your updated resume to [email protected] and include the job title in the subject line.
Job Types: Full-time, Contract
Application Question(s):
- Do you have an engineering or related science bachelor degree?
Education:
Experience:
- Quality Engineer: 3 years (Required)
Language:
- Spanish (Required)
- English (Required)
Ability to Commute:
- Añasco, PR 00610 (Required)
Work Location: In person
