Quality/Regulatory Manager posted June 14, 2016

 

A&E Medical is looking to fill a Manager of Quality and Regulatory position. 

Position Summary

Quality/Regulatory (QARA) Manager is responsible for the Quality and Regulatory compliance and acts as the Quality System Management Representative.  The QARA Manager is a member of the Alto Medical Management Team and is responsible for providing leadership and technical support to the organization ensuring that the Quality System is effectively defined, implemented, and maintained.  The QARA Manager has responsibility for ensuring that product quality is maintained and monitored while meeting Quality and Business objectives which the Quality Manager has input into developing.  The QARA Manager has supervisory responsibility for the Quality Department.  The QARA Manager ensures compliance with all applicable regulatory requirements and Alto Medical policies and procedures.

Essential Duties & Responsibilities

Ensures that the Alto Medical organization follows Good Manufacturing Practices and Quality System Procedures as defined by Alto’s Employee Handbook and Quality Manual to insure that applicable Regulatory and ISO 13485 requirements are met.

  • Meet commitments on time with accuracy and attention to detail.
  • Administrator of all Quality Procedures, Document Control and Records.
  • Responsible for all inspection and test methodologies and gage R&R as well as all Quality inspection activity (receiving, in-process, final release and post sterile)..
  • Responsible for management of training program.
  • Responsible for Material Review Board (management of nonconforming material).
  • Champion of failure investigation, root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
  • Responsible for environmental controls and monitoring of controlled environments and product.
  • Manage internal auditing to evaluate and improve compliance. Responsible for ensuring timely conduct and closure of audits and thoroughness of content and corrective actions.
  • Responsible for supplier management including corrective actions and failure investigations related to supplied materials and service.
  • Participates in the management of external audits from customers and regulatory bodies.
  • Responsible for Quality Metrics, ensuring that they are accurate, appropriate and prepared in a timely manner.
  • Provides technical support for Engineering (statistical support, DOE, test methods, etc) and provides review for protocols and reports to ensure data integrity and appropriate documentation for regulatory compliance.
  • Responsible for post market vigilance including complaint management, medical device reporting globally, as well as recall and field corrective action
  • Responsible for sterilization processes (gamma and EO) and final release of product including post sterilization testing. Also responsible for maintaining the validation of the sterilization processes.
  • Provides solutions to a variety of technical problems which require the regular use of creativity and knowledge of advanced Problem Solving / Lean / Six Sigma / DOE skills.
  • Supervisory responsibilities for Quality Department personnel and work load.
  • Responsible for identifying the development needs of staff and managing the resources to meet needs identified.
  • Responsible for providing oversight and guidance on regulatory submission and country registration requirements. Includes management of outside resources who may provide the technical expertise and manpower to complete needed regulatory documents and submissions.

Non-Essential Duties & Responsibilities

  • Performs other duties as assigned by immediate supervisor.

Qualifications

  • A minimum of five to seven years related experience in the medical device industry.
  • A minimum of one to three years of supervisory experience, preferably with project management skills.
  • An understanding of global regulatory requirements for medical devices.
  • A Bachelor’s degree in engineering or related discipline is required.
  • Strong mechanical aptitude with manufacturing experience.
  • Capacity for solid decision making in situations relating to regulatory compliance, product quality, and quality system requirements.

Skills & Abilities

SKILLS & ABILITIES:

  • Well developed written and verbal communication skills. Ability to effectively present information to senior managers and other employees of the organization.
  • Ability to solve practical problems and deal with a variety of variables.
  • Ability to interpret a variety of instructions furnished in written and oral form.
  • Experienced with a wide variety of measurement devices (vision system, caliper, micrometers, and variety of gages).

COMPUTER SKILLS:

  • Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
  • Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization.

Physical Requirements

  • While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel, frequently required to talk or hear, occasionally required to stand, walk, reach with hands and arms, climb or balance, stoop, kneel and crouch.
  • Must be able to work in manufacturing environments exposed to moving mechanical parts and fumes or airborne particles.
  • The employee must occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision.
  • The employee must be willing and able to travel within and outside the US.
  • Ability to work in office setting.

Notes

This job description is not intended to be an exhaustive list of all skills, duties, responsibilities, or qualifications associated with this position.  While this list is intended to be an accurate reflection of the current job, the company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change.  Employees are held accountable for all duties of position.

Interested candidates should contact:

Dana Rodriguez (Management Representative for A&E)
email:  rodriguez.dana@gmail.com
The company website is AEMedical.com.  We are located in Farmingdale, NJ.