Quality Manager

Molex Clinton , MA 01510

Posted 3 months ago

Job Description:

Position Overview:

Phillips-Medisize, LLC is seeking a Quality Manager to provide direction and leadership to the Quality team in 2 Massachusetts divisions and ensure compliance to customer requirements and regulatory standards.

Essential Functions:

  • Provide direction and leadership to the quality team including talent acquisition, alignment on goals & objectives, managing performance, facilitating career development and addressing disciplinary issues.

  • Foster open communication with staff and up the management chain for alignment on important information and issues.

  • Serve as, or lead, the Management Representative, ensuring that the facility meets internal policies and requirements, customer requirements, and ISO 13485 standards.

  • actively lead quality-regulatory improvements and innovations focused on Cost of Quality, CAPA and QMS process improvements.

  • Implement and govern quality-regulatory systems & procedures at the site level that align with Phillips Medisize's global QMS and support appropriate manufacturing and operational consistency.

  • Minimize exposure to regulatory risk through continual awareness and communication of current local, state and federal regulations that impact the medical device industry. Ensure that Sales, Marketing and Program Managers appropriately consider and account for regulatory requirements in new program launches coming into the sites.

Position Qualifications

Qualifications, Skills and Abilities

  • Bachelor degree in quality, business, engineering, or technical certification in a quality discipline.

  • 5+ years' experience managing employees.

  • Advanced knowledge of FDA and international regulations and standards related to medical device (e.g. MDD, 21 CFR 11, 820 and ISO 13485, 14971)

  • Advanced knowledge of quality control tools and processes; SPC, DOE, root cause analysis and inspection methodology

  • Clear and concise written, verbal and presentation communication skills.

  • Data driven problem solving and decision-making skills.

This position does not qualify for VISA sponsorship

About Phillips-Medisize, LLC

Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.

Learn more...

Visit us: www.phillipsmedisize.com

Twitter: www.twitter.com/phillipsmedisiz

YouTube: www.youtube.com/user/PhillipsPlasticsCorp

Linkedin: www.linkedin.com/company/Phillips-Medisize

Phillips-Medisize History: www.phillipsmedisize.com/about-us/history

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