QUALITY MANAGER Job in Valencia 91355, California Us

    

Bioness Inc. ™. (www.bioness.com) develops, manufactures and markets innovative neuromodulation products that aid individuals in the recovery from central nervous system disorders such as stroke, multiple sclerosis, spinal cord injury, brain injury and other neurological disorders.  The Company also distributes rehabilitation devices including the ZeroG Overground Gait and Balance Training System, Dynavision D2 Visuomotor Training Device and WOODWAY medical treadmills.

 

The NESS L300® Foot Drop System and the NESS H200® Hand Rehabilitation System, cleared for use by the Food and Drug Administration (FDA) and approved by the European Union (CE Mark), are designed to enable patients to achieve new levels of physical independence and productivity.

 

ZeroG® and the ZeroG Logo are trademarks of Aretech, LLC. | www.aretechllc.com

 

Dynavision D2™ and the Dynavision D2 Logo are trademarks of Performance Enterprises.

 

Bioness is searching for an experienced, organized and pro-active Quality Manager.  This position is responsible for maintaining the quality systems at Bioness to be in compliance with applicable regulatory requirements.  Manages the following functions:  inspection and test, compliant investigation, document control, internal and supplier audits, sales and customer care processes, and quality metrics reporting.

 

SPECIFIC DUTIES AND RESPONSIBILITIES:

Oversees the performance of all QA functions, including product release, document control and quality assurance engineering, to assure that products and processes meet company and regulatory requirements/standards. 

 

Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality and systems consistent with department and company operating objectives.

 

Responsible for all quality concerns as they relate to sales and customer care processes.  This includes investigating, evaluating and reporting on individual customer product complaints and compliance with all legal protocols, such as HIPAA etc.

 

Provides technical assistance and direction to the other functional groups.  Interfaces with regulatory agencies in conjunction with new device submissions and during routine audits, field complaint investigations and technical interchanges to present the company’s viewpoint.

 

Oversees and/or directs the investigation of excursions in manufacturing or other related operations resulting in abnormal operation rejections.  Resolves nature of cause, impact, disposition and corrective action.

 

Responsible for initiating investigations resulting from nonconformance, product incident reports or excursions, technical documentation of investigation results and preparing correspondences to regulatory authorities.

 

Reviews and approves all products, processes, and material related nonconformance for technical accuracy, completeness, and justifications supporting recommended actions to be taken.

 

Directs and assists in the development and issuance of all written procedures, Bills of Materials and product drawings, ensuring that the company complies with the requirements of its cGMP’s and those of the regulatory agencies.

 

Ensures that Quality Assurance department policies and procedures are maintained and department personnel are operating in accordance with established procedures.

 

Able to react to change productively and to perform other essential tasks assigned.

 

EDUCATIONAL REQUIREMENTS:  BS in Engineering, Master’s degree preferred.  Current knowledge of FDA and international quality systems requirements are a must.  ASQC certification is preferred.

 

EXPERIENCE:  Ten years of quality management experience in the medical device industry.

 

KNOWLEDGE, SKILLS AND ABILITIES:

·         Broad knowledge of quality policies.

·         Thorough knowledge cGMP’s, QSR’s, ISO and medical products.

·         Familiarity with requirements for submissions to regulatory agencies.

·         Strong knowledge of CAPA.

·         Experience in interfacing with FDA and notified bodies during audits.

·         Experience implementing ISO 13485.

·         Experience in writing audit responses.

·         Solid knowledge of risk management, validations, design controls, process development, monitoring, statistical controls and root cause analysis.

·         Experience with the management of outsourcing and vendor management.

·         Must be capable of applying statistical techniques and process improvement techniques to operational issues of significant scope and complexity.

·         Must have product release, containment and recalls experience.

·         Must have working knowledge of all phases of company’s manufacturing and quality operations.

·         Excellent written and verbal communications skills required.

·         Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside the company.

·         Ability to manage multiple priorities and tasks in a dynamic environment with attention to detail.

·         Ability to travel globally 20% of the time.

 

 

Bioness Inc. ™ offers a competitive compensation package, excellent benefits and growth opportunities.  We are an equal opportunity employer, committed to hiring a diverse workforce, M/F/D/V.