Quality Assurance Coordinator - Healthcare jobs in Trenton, NJ

Quality Assurance Coordinator

Job Title: Quality Assurance Coordinator

Department: Quality Assurance

Reports To: Quality Assurance Manager

Location: 144 Railroad Drive, Ivyland, PA 18974

General Summary:

The Quality Assurance Coordinator is responsible for performing quality assurance activities as they relate to the manufacture, inspection, and distribution of products produced by the company.

Essential Functions:

§ Preferred knowledge of Quality System standards and regulations including 21 CFR 820 and ISO 13485/14971.

§ One year or more experience in the Quality Assurance/Control, Medical Device industry.

§ Attention to detail, strong in reading and comprehension.

§ Lead Quality Assurance activities needed to support manufacturing.

§ Review and approval of quality management system documentation as it relates to manufacturing of product(s) produced by the company.

§ Provide training to manufacturing personnel/groups regarding applicable quality and regulatory requirements relating to the manufacture of products produced by Wassenburg Medical, Inc.

§ Identifying, documenting and processing of non-conforming product(s) identified in receiving inspection and manufacturing.

§ Must be able to communicate precisely and accurately to all levels of the organization.

§ Strong interpersonal and communicative skills.

§ Strong problem solving skills.

§ Electronical and mechanical troubleshooting skills.

§ Technically inclined. Self-oriented, self-organized, and able to work with minimum supervision.

§ Other duties as assigned by management

Education Required:

High School Diploma, Associate Degree, or two or more years’ experience in a quality assurance/control position.

Practical Experience:

Proficient in the use of a computer. Word and Excel knowledge required.

Aptitude Required:

· Mental: Constantly

· Mechanical: Occasionally

· Verbal: Constantly

· Personal Initiative: Very Important

Physical Requirements:

• Standing: Occasionally
• Walking: Occasionally
• Sitting: Constantly
• Bending/Stooping/Squatting: Occasionally
• Climb Stairs: Rarely
• Lying Down: Rarely
• Push or Pull: Occasionally
• Reach Above Shoulders: Rarely
• Climb Ladders: Rarely
• Grasp/Grip: Rarely
• Finger Dexterity: Rarely
• Writing/Typing: Constantly
• Driving/Operating Equipment: Rarely
• Vision (Beyond Arm’s Length): Rarely
• Lifting/Carrying:
• Over 150 lbs: Rarely
• 76 – 150 lbs: Rarely
• 51 – 75 lbs: Rarely
• 26 – 50 lbs: Rarely
• 10 – 25 lbs: Occasionally
• 1 – 9 lbs: Occasionally

Environment:

• Hearing Requirements: Constantly
• Speaking Requirements: Constantly
• Working Indoors: Constantly
• Working Outdoors: Rarely
• Working in Confined Space: Rarely
• Exposure to Fumes, Chemicals, Solvents, Caustics, etc.: Occasionally
• Extreme Temperatures: Rarely
• Eye/Hand/Foot Coordination: Rarely

Reasoning Development: Apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagrammatic form. Deal with several abstract and concrete variables.

Mathematics: Add, Subtract, Multiply, Divide.

Reading: Reads and able to interpret schematics, drawings, and other technical literature.

Writing: Prepare business letters, expositions, summaries, and reports with proper format.

Speaking: Speak clearly and distinctly.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• What is your salary requirement?

Education:

• Bachelor's (Preferred)

Work Location: In person