CAPA, Quality, Supplier Quality, FDA, CGMP, SPC, L Job in Harrisburg Pennsylvania (PA)

CAPA, Quality, Supplier Quality, FDA, CGMP, SPC, Lean, testing CAPA Engineer, Quality and compliance, CFR 210/211, Supplier Quality, FDA, CGMP, SPC, Lean, testing - Skills Required - CAPA Engineer, Quality and compliance, CFR 210/211, Supplier Quality, FDA, CGMP, SPC, Lean, testing

Supplier Quality/Compliance Engineer
Direct Hire/Perm
Harrisburg, PA
Contact: (see below)

We are currently seeking a degreed, experienced engineer with a background in supplier quality, qualification and compliance to take on a key role reporting internally to the VP of Quality and RA.

This engineer will personally be responsible for the following internally:
Supporting Quality Management System activities such as supply chain
CAPA initiatives.
The application and analysis of testing and inspection procedures.
Using metrology and statistical methods to diagnose and correct improper quality control practices, understanding quality cost concepts and techniques.
Developing and administering management information systems and auditing quality systems for deficiency identification and correction.
This position is responsible for working with R&D on equipment and process qualifications and validations.

In this role you will actively:
Perform supplier audits
Lead supplier corrective and preventative action (CAPA) activities
Coordinate CAPA program working with cross functional resources to drive technical problem solving ensuring timely closure of non-conformances
Coordinate complaint program ensuring timely reporting, analysis and resolution
Maintenance of the database for the CAPA program, complaint handling, internal auditing and quality metric reporting
Act as a quality liaison with suppliers and customers
Plan and implement product and process design verification activities
Support equipment and process qualification and validation activities
Support the validation of sterilization processes
Developing and reviewing internal test protocols and procedures, including Quality Metric reporting and statistical process control


Education/Experience Required:
EDUCATION:
o The qualified candidate must have a college degree (Bachelor's degree in a science field preferred).
EXPERIENCE:
o A minimum of 5 years experience in quality engineering or management in a FDA regulated industry.
o A thorough understanding of cGMPs for medical devices, 21 CFR part 820.
o Direct experience with ISO standards for medical devices and quality management systems.
o Experience with drug cGMPs, 21 CFR part 210/211, highly desirable.
o Computer skills in MS Word, Excel and database programs required.
o Experience with electronic document control systems is desirable.
o Familiarity with and certification in Six Sigma, LEAN manufacturing or other vigorous quality control programs is highly desirable.


If this sounds like a strong fit for you, please get in touch with me immediately for consideration at my email address, (see below) . - RH-CAPASupplierQAEngPA - , , , , , CyberCoders CyberScientific