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: