Quality Assurance Manager

1 month ago

Marquand, Missouri, United States Intersurgical, Inc. USA Full time
About Us

Intersurgical Inc. is a leading global manufacturer of medical devices, partnering with healthcare providers and organizations to deliver innovative solutions that impact patient lives.

We prioritize quality and collaboration, fostering a culture where diverse perspectives and experiences are valued.

Our Culture

We celebrate our workplace as a space where everyone can be their authentic selves, welcoming individuals with diverse backgrounds, veterans, and those with disabilities.

We strive for innovation and excellence, encouraging unique experiences and viewpoints to drive growth and improvement.

Purpose

As the Quality Assurance Supervisor, you will oversee the Quality team in a manufacturing environment, assisting the VP of Quality Assurance & Regulatory Affairs in maintaining quality standards, conducting investigations, and collaborating with Production and Engineering on technical and quality issues.

You will play a crucial role in maintaining and controlling quality assurance programs, supervising all aspects of quality assurance and technical issues impacting Intersurgical Inc. and its clients.

Key Responsibilities
  • Supervise Quality staff, including scheduling, time records, evaluations, counseling, and performance documentation
  • Assist in maintaining compliance with domestic and international quality standards, internal, customer, certification body, and regulatory
  • Ensure standard operating procedures (SOPs) are implemented, maintained, and continuously improved
  • Support VP of QA/RA in preparing and coordinating external audits
  • Coordinate and communicate quality activities with various company departments
  • Perform and assist with internal audits
  • Generate and maintain documentation for NCMRs & CAPAs for internal Non-Conforming products and incoming materials
  • Coordinate and assist with ECN process and supplier approval and maintenance
  • Document calibration activities and assist with directing quality staff in inspections
  • Communicate with suppliers regarding product acceptance or rejection
  • Develop and implement quality procedures to ensure products meet customer specifications
  • Manage customer document requests and other quality-related documentation
  • Proactively identify opportunities to improve quality activities and communication
  • Provide backup support for Quality team members and other roles as needed
Requirements
  • 2-3 years of supervisory experience in a manufacturing environment
  • Proficient in Microsoft Office products, including Outlook, Excel, and Word
  • Ability to see the big picture while focusing on process and procedures
Preferred Qualifications
  • 3-5 years of Quality experience
  • Bachelor's degree or equivalent experience in a related field
  • Experience in auditing, inspections, and quality assurance
  • Technical knowledge of medical devices and quality systems
  • Medical manufacturing facility experience
Work Environment

Temperature-controlled facility with office and light manufacturing environment; non-smoking; safety hazards minimal with daily use of some chemicals; company-provided smock and hairnet mandatory in all controlled production areas.

Intersurgical Inc. is an Equal Opportunity Employer, committed to a diverse environment and does not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition, or disability.

Benefits
  • Competitive salary
  • Multiple opportunities for career growth and development
  • 401k match and profit sharing
  • Paid vacation and holidays
  • Medical, dental, and vision benefits
  • More...

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