Quality Engineer – Jessup, PA

 

Company:

MTF

Location:

Jessup, PA 18434

Status:

Full Time, Employee

Job Category:

Quality Assurance/Safety

Occupations:

General/Other: Quality Assurance/Safety;Production Quality Assurance;Six Sigma/Black Belt/TQM

Career Level:

Experienced (Non-Manager)

Education Level:

Bachelor's Degree

 

 

 

 

 

Job Description

Summarize the primary function of the position:

To support MTF’s quality system by establishing and maintaining the validation program in compliance with applicable government regulations and the standards of the American Association of Tissue Banks, the U.S. Food and Drug Administration, and other regulatory bodies.

Describe the major elements of the position in order of importance:

1.       Designs, coordinates, performs, analyzes, reports, and maintains process validations and equipment qualifications.  This includes but is not limited to writing protocols, overseeing or performing protocols, and reporting results to management

2.       Assists Quality Assurance, Research & Development, and other departments with product development studies, validation and other engineering projects;

3.       Works on interdepartmental teams to develop specification, procedural and regulatory compliance (cGMP, QSR, GTP, and AATB Standards, as applicable) of tissue forms and medical devices.

4.       Coordinates special project testing with outside consultants as needed.  Performs analysis of data and reports results to management.

5.       Composes and updates Quality Assurance Standard Operating Procedures, specifications, and validation procedures.  Assists other departments with procedure controls.

6.       Assists in the identification and development of production controls for new products.

7.       Supports the regulatory submission process for tissue-based products and medical devices.

8.       Represents MTF on matters of quality with QA personnel, other departments within MTF, procurement agencies, and suppliers of goods and services used in tissue processing and distribution.

9.       Assists on special projects and performs additional duties as assigned.

Job Qualifications (education, certification, experience, knowledge, skills, physical requirements)

1.       Bachelor’s degree in science or engineering.

2.       Minimum two years of quality assurance or FDA regulatory experience required; industry certification extremely helpful (i.e., ASQ-CQA, CQE; CTBS).

3.       Excellent communication, organizational, and technical writing skills.

4.       Must be computer literate, including Microsoft Word and Access, and statistical software.

 

Please submit resume and salary requirements to HRDept4@mtf.org . Resumes received without salary requirements will not be reviewed.

 

Contact:

Company:

MTF

 

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