Quality Engineer - 60837 (Añasco)

*Title: Quality Engineer- ***** (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 Chemical, Biomedical, Mechanical, or Industrial Engineering or related science.
* Experience in the medical device and/or pharmaceutical manufacturing environment; on a *Quality Engineer *position.
* 5 to 7 years minimum experience in an FDA regulated environment.
* ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.
* Experience with Quality System Regulation (QSR), ISO, Design Control and Process Validation guidelines.
* Lyophilization experience preferred.
* Knowledge of qualifying new facility additions - HVAC, water filter systems.
* Must have prior experience with ISO cleanrooms.

*Qualifications:*

* Able to develop technical documentation such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others.
* Will have a fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements.
* Will have a basic understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
* Will be able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
* Will be able to plan, control and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling and measurement systems.
* Will have basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, assessment tools and reporting.
* Will have a thorough understanding of problem-solving and quality improvement tools and techniques.
* Will be able to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
* Strong Project Management skills.
* Knowledge in Lean and Six Sigma concepts.
* Knowledge of statistical techniques: SPC, DOE, Process Capability and Gage R & R, etc.
* Use of statistical process Minitab tools is preferred.
* Working knowledge of computers and business software (MS Office, MS Project, VISIO) required.
* Experience in biomaterials preferred.
* Experience in cGMP, cleaning methods and validations preferred
* Must have excellent communication skills and a strong track record of working cross-functionally.
* Must have demonstrated ability to think strategically.
* 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 ****** 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:
* Bachelor's (Required)

Experience:
* Quality Engineer: 5 years (Required)

Language:
* Spanish (Required)
* English (Required)

Ability to Commute:
* Añasco, PR ***** (Required)

Work Location: In person