Freudenberg Nonwovens, LP

Quality Manager

Freudenberg Nonwovens, LP • $90K — $120K *
Beverly, MA 01915In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant field
  • 7 years of experience in Quality, Manufacturing, or Product Development
  • 5 years minimum experience in the medical device sector
  • Over 5 years of experience in managing, coaching, and mentoring staff
  • Strong experience in a metric-driven culture
  • Participation or leadership in Quality audits
  • Knowledge of ISO Quality Systems and FDA GMP/QSR

Responsibilities

  • Lead the development and management of quality systems to ensure compliance and effectiveness
  • Act as the Management Representative to regulatory bodies and oversee management review activities
  • Manage client quality system audits and address concerns promptly
  • Serve as the primary contact for quality-related customer inquiries
  • Respond to field complaints in accordance with regulations
  • Participate in strategic planning, ensuring quality requirements are integrated into goals
  • Involve in new product development to define and uphold quality standards
  • Collaborate with operational teams to ensure management controls and product lifecycle meet quality expectations
  • Ensure site quality performance indicators align with global metrics
  • Support lean and continuous improvement initiatives, alongside safety programs
  • Plan quality activities, allocate resources, and establish priorities for goal achievement
  • Develop staff within company management systems, fostering a high-performance culture

Benefits

  • Opportunities for professional development and career advancement
  • Participation in innovative quality processes and projects
  • Involvement in a culturally rich and inclusive organization
  • Engagement in lean and continuous improvement initiatives
Full Job Description
Responsibilities:

  • Responsible for leading, development, and management of effective and compliant quality systems and work closely with various cross functional members of site to ensure all requirements are described and meet the needs of regulations and functional excellence.
  • Serve as Management Representative responsible for representing site to all regulatory bodies including registered notified bodies and ensuring management review activities are conduct per regulations.
  • Manage all client quality systems audits and ensure timely response to any audit concerns.
  • Act as the primary contact for customers regarding quality related issues/activities.
  • Ensure all field complaints are response per regulatory requirements.
  • Participate in strategic planning activities to ensure that all quality related requirements are considered when establishing strategic goals and objectives.
  • Participate in new product/project development to ensure quality requirements are established.
  • Work directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, improve yield and product quality, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Ensure that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics.
  • Participate and support lean/continuous improvement initiatives and safety initiatives.
  • Ensure the quality activities are planned; resources allocated; priorities established and activities executed to meet goals,
  • Working within the people management systems in the Company to develop others (performance management, rewards and selection process); and Creating an energizing work environment that supports the Company's high performance culture while ensuring and efficient and flexible organization.


Qualifications:

  • Bachelor's degree
  • 7 years of Quality, Manufacturing, and/or Product Development, experience.
  • 5 years minimum of medical device experience.
  • 5+ years experience in demonstrated ability to manage, coach and mentor employees.
  • Experience in a metric driven culture.
  • Previous experience participating in or leading a Quality audit or section of an audit.
  • ISO Quality Systems requirements and FDA GMP and QSR.
  • Electronic Quality Management System.
  • Able to review and analyze data and documentation.
  • Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.


Freudenberg Medical LLC

About Freudenberg Nonwovens, LP

Freudenberg Nonwovens is a leading manufacturer of nonwoven fabrics for a variety of industries, including automotive, construction, filtration, healthcare, and hygiene. The company's products are used in a wide range of applications, from air and liquid filtration to wound care and feminine hygiene. Freudenberg Nonwovens is a subsidiary of the Freudenberg Group, a global technology company with operations in more than 60 countries. The company was founded in 1849 and is headquartered in Weinheim, Germany. Freudenberg Nonwovens has manufacturing facilities in North America, Europe, and Asia.
Learn more about Freudenberg Nonwovens, LP
Size
2,000 employees
Industry
Manufacturing & Automotive
* Ladders Estimates

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