Quality Engineer III(2688)

Summary Description:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this QE position:

Must have prior experience with ISO cleanrooms.
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 preferred.
Knowledge of qualifying new facility additions - HVAC, water filter systems
Med device experience preferred not required
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.
Problem solving and analytical thinking skills
Strong Project Management skills
Strong skills in technical writing
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 cGMP, cleaning methods and validations preferred.
Ability to interact cross-functionally required.
Strong interpersonal skills
Teamwork oriented and self-starter
Fully bilingual (English/Spanish)

Education and/or experience:

BS in Chemical, Biomedical, Mechanical, or Industrial Engineering.
5 to 7 years minimum experience in an FDA regulated environment.
ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.
Experience in biomaterials preferred.

Other Requirements:

**CANDIDATE MUST LIVE IN PUERTO RICO**
No relocation nor travel expenses.

Job Types: Full-time, Contract

Work Location: In person

Human Resources Generalist III(2699)

Summary Description:
Manages the day-to-day operations of the Human Resource office.

The HR Generalist manages the administration of the human resources policies, procedures and programs.
The HR Generalist carries out responsibilities in the following functional areas: departmental development, Human Resource Information Systems (HRIS), employee relations, training and development, benefits, compensation, organizational development, and employment.
The Human Resources Generalist originates and leads Human Resources practices and objectives that will provide an employee-oriented, high performance culture that emphasizes empowerment, quality, productivity and standards, goal attainment, and the recruitment and ongoing development of a superior workforce.
The Human Resources Generalist coordinates implementation of services, policies, and programs through Human Resources staff.
Reports to the Human Resources Director.
Assists and advises company leads about Human Resources issues.

Education & Experience

Bachelor’s degree required.
7+ years of experience.

Other Requirements:

**CANDIDATE MUST LIVE IN PUERTO RICO**
No relocation nor travel expenses.

Job Types: Full-time, Contract

Work Location: In person

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