Manager, Complaints & Quality Control

Volcano Corporation provides rewarding and challenging employment opportunities for those qualified and selected individuals wishing to join us as we develop, market, and manufacture products that improve the overall quality of medical care.

 

Come join Volcano Corporation - a team leading the way!

 

JOB SUMMARY:

·  Manages the Complaint Handling, Quality Control Final, and Receiving Inspection functions.  Establishes and manages the necessary quality programs to ensure the Company manufactures and ships devices meeting their specifications.

 

RESPONSIBILITIES:

·  Develops and ensures the execution of objectives for the Complaint Handling, Quality Control Final, and Receiving Inspection functions in alignment with Quality Assurance department goals and objectives.

·  Ensures the Complaint Handling, Quality Control Final, and Receiving Inspection functions operate according to procedures and provides direction to staff.  Manages personnel, including coaching, mentoring, evaluating performance, and disciplinary actions.

·  Provides technical expertise regarding measurement and inspection techniques, including geometrical tolerance principles, choice of equipment, and sampling plans.

·  Manages the environmental validation and monitoring program.

·  Performs on-going employee training for Quality Manual and Quality System updates.

·  Oversees sterilization and sterilization validations.

·  Coordinates the disposition of non-conforming material.

·  Participates in internal and external audits.

 

EDUCATION: 

·  Requires a Bachelor's degree in Engineering

 

KNOWLEDGE AND EXPERIENCE: 

·  Requires 5+ years experience in quality assurance in the medical device industry

·  Requires 3+ years experience in complaint handling

·  Requires 3+ years experience in inspection and metrology

·  Requires 3+ years experience in microbiology and sterilization in the medical device industry

·  Requires 3+ years in a management or supervisory position

·  Proven experience in leading others with a proactive attitude

·  Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations (QSR), and ISO 14385 requirements

 

SKILLS AND ABILITIES: 

·  Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including management and outside business associates

·  Advanced Microsoft Office skills

·  Ability to organize and prioritize workflow and to meet established timeframes

·  Ability to maintain updated knowledge of procedures, products and activities of assigned area

·  Ability to coordinate the work of others

·  Ability to accurately proofread documents

·  Ability to maintain confidentiality

 

PROBLEM SOLVING AND DECISION MAKING: 

·  Systematically analyzes problematic situations and develops solutions consistent with organization objectives

 

SUPERVISORY RESPONSIBILITY: 

·  Manages exempt and nonexempt staff; makes hire, performance evaluation, termination, promotion and merit decisions

 

TRAVEL REQUIREMENTS: 

·  May be required to travel both domestically and internationally to Volcano offices, customer and vendor locations

 

Volcano offers a competitive comprehensive Benefits Package to regular full time employees.

 

Qualified candidates please email resume to jobs@volcanocorp.com

 

 

To learn more about Volcano Corporation go to www.volcanocorp.com

 

EEO/AA M/F/V/D

 

NOTE:    The above statements are intended to describe the general nature and level of work being performed by incumbents.  They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents.  Incumbents may perform other duties as assigned.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Management retains the right to add to or change the duties of the position at any time.