Job Description

The Quality Manager role has primary responsibility for supporting and managing the Quality Management System assisting with development and implementation of standard operating procedures in compliance with applicable FDA, ISO-13485, CE and other regulatory certification requirements as well as with internal policies and objectives.

 

Job Functions (Essential):

  • Collaboration with cross-functional leads to establish quality specifications for all products and processes.
  • Ensure appropriate quality planning and procedures for new products, design changes and process modifications
  • Establish tools to monitor quality processes and prepare reports of findings on a regular periodic basis and present at management review meetings
  • Establish and implement appropriate methods such as design of experiments, sampling techniques and data analysis for products and processes
  • Perform supplier qualifications
  • Help resolve quality problems and product performance issues using sound engineering principles and problem-solving techniques including root cause and economic analyses
  • Ensure that inspection and approval of incoming materials and work-in-process is appropriate, in conformance with specifications and adequately documented
  • Perform routine monitoring reviews/audits of Design History Files to assure compliance to the company's procedures.
  • Communicating with suppliers, potentially involving resolution of NC’s (non-conformance issues) or manufacturability questions.
  • Keeping team informed of progress and possible issues.
  • Completing work assignments in a thorough, consistent, and punctual manner
  • Adhering to company work hours, policies, procedures, and rules governing professional team behavior.
  • Maintaining professional relationships with company employees, clients, and customers, both internal and external.
  • Adhering to company and professional ethics governing the handling of confidential information and the observation of confidentiality both during and after employment.

 

Required Education & Experience:

  • Bachelor’s degree.
  • At least 7 years Medical Device industry experience.
  • Minimum of 5 years Regulatory Affairs and/or Regulatory Operations experience.
  • Knowledge of U.S. and international regulations including FDA, ISO, and cGMP guidance documents.
  • Ability to manage multiple projects, with the ability to adapt to changing priorities and negotiating solutions.
  • Ability to work with both internal cross-functional team members and external consultants and advisors.
  • Professional, proactive demeanor, and strong interpersonal skills.
  • Excellent written and verbal communication skills.
  • Excellent organizational skills.
  • Good interpersonal and communication (oral and written) skills to work effectively with others.
  • Good organizational, planning and follow-up skills.
  • Willing to ask for clarification and learn new approaches to familiar problems.
  • Proficient with Microsoft Windows and Microsoft Office.

 

Preferred Skills and Experience:

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