QUALITY ASSURANCE ENGINEER

POSITION SUMMARY:

The Quality Engineer is responsible for managing equipment/process validation.  Leader of the CAPA program for customer complaints as well as internal corrective actions. Coordinates and improves quality in the areas of suppliers, gaging requirements and design.  Familiar with standard concepts, practices and procedures for compliance purposes.  Relies on experience and judgment to plan and accomplish goals.  Works independently with minimal supervision.

 

ESSENTIAL DUTIES AND RESPONSIBILITES:

 1) Directs equipment/process and validation IQ’s, OQ’s & PQs for adherence to FDA QSR’s.

 2) Coordinates with suppliers and identifies areas for quality improvements.

 3) Determines gaging requirements and assists in gage design.

 4) Leader of CAPA that determines root causes, corrective actions and follow through.

 5) Reviews and dispositions nonconforming materials.

 6) Performs internal audits to ensure quality compliance.

 7) Develops calibration standards.

 8) Monitors and improves the scrap and rework area.

 9) Leads in development of control plans.

10) Assists in contract/order reviews.

 

NON-ESSENTIAL RESPONSIBILITES:

1) Participates in design review for the purpose of gauging needs and meeting inspection criteria.

2) Assists with FMEA’s.

 

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

1) Regulatory cGMP, QSR and ISO knowledge base

2) Computer literate/proficient with Word and Excel software programs

3) Negotiation and problem solving skills

4) Good oral and written communication skills; ability to properly speak and write in the English language

5) Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R)

6) Experience in the area of manufacturing operations

7) Ability to multi-task, prioritize and work independently

 

EDUCATION AND EXPERIENCE:

1) M.S. or B.S. degree in Engineering; or equivalent quality engineering work experience of five (5)–eight (8) years.

2) Minimum of three (3) years as a Quality Engineer with medical device experience in manufacturing operations, process qualification, and quality engineering.

3) ASQ Certification a plus.

 

 

 

 

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job the employee is frequently required to sit, stand, and walk as the position is in an office setting, and to speak and hear for communication purposes.  The employee is occasionally required to use hands to feel an object, and reach with hands and arms.  Vision abilities required by this job include being able to see clearly so one can read documents, and see at a close distance for observation purposes on the manufacturing floor and in an office setting when discussing product and other information. 

 

WORKING CONDITIONS:

Office and manufacturing environment with extensive time spent on the manufacturing floor.  The individual must be able to adhere to all manufacturing policies when entering the manufacturing area. This position has a minimal amount of chemical exposure but has exposure to loud, constant noise while on the manufacturing floor.  Non-smoking building/work environment.

 

Qualified applicants please submit resume along with salary requirement to:

Email:  kwjobs@teleflexmedical.com

Apply online:  http://www.teleflexmedical.com/careers