About Us
Intersurgical Inc. is a global leader in medical device manufacturing. We partner with providers, manufacturers and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.
Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.
Our Culture
At Intersurgical Inc., we celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic selves.
We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.
Purpose
As the Quality Assurance Supervisor, you will be responsible for overseeing the Quality team members in a manufacturing and assembly environment. You will assist the VP of Quality Assurance & Regulatory Affairs with the application and maintenance of quality standards for the company, conducting quality assurance investigations, collaborating with Production and Engineering on technical and quality issues. The Quality Assurance Supervisor role is essential in maintaining and controlling quality assurance programs and supervising all aspects of quality assurance and technical issues which impact Intersurgical Inc. and the clients we support. You’ll have the opportunity to learn from the individuals that have played a part in building the business while helping thousands of people worldwide.
- Responsibility of supervising the Quality staff, which includes scheduling, approving time records, periodic evaluation, counseling, and performance documentation
- Assist with maintaining compliance with all applicable domestic and international quality standards – internal, customer, certification body, regulatory.
- Assist with ensuring standard operating procedures (SOPs) are implemented, maintained, and continuously improved.
- Assist VP of QA/RA with the preparation and support activities for all external audits
- Coordinate and communicate quality activities with various company departments
- Perform and assist with the internal audit process
- Generate and maintain documentation for NCMRs & CAPAs for internal Non-Conforming products and incoming materials, assisted in the investigation process as needed
- Coordinate and assist with ECN process when needed
- Coordinate and assist with the approval and maintenance process for suppliers
- Coordinate and document calibration activities
- Assist with directing quality staff in the acceptance of incoming inventory inspections, outgoing inspections and in production inspections; maintain documentation as required
- Communicate with suppliers regarding acceptance or rejection of purchased product
- Assist with the development and implementation of quality procedures to assure all products are manufactured to meet customer specifications.
- Manage customer document requests and other quality related documentation.
- Proactively identify opportunities to improve quality activities and communication.
- Provide back-up support for Quality team members and other roles, as necessary.
- Other duties as assigned by the manager/supervisor.
What We’re Looking for
- 2-3 years of supervisory in a manufacturing environment
- Proficient in Microsoft Office products including Outlook, Excel and Word.
- Ability to see the big picture while focusing on the process and procedures necessary to produce deliverables.
Preferred
- 3-5 years Quality experience
- Bachelor’s degree or equivalent experience in related field
- Experience in auditing, inspections, and quality assurance.
- Technical knowledge of medical device and quality systems.
- Medical manufacturing facility experience
Requirements
- Must be able to speak, read and write English
- Must be able to sit, stand and/or walk for extended periods of time
- Must be able to lift 50 lbs
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 that takes pride in a diverse environment. We do 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, or any other legally protected status.
Benefits
We are passionate about the well-being of others and that begins with caring for our people.
- 💰 Competitive salary
- 🧠 Multiple opportunities to be challenged and step up your career in a fast-growth company
- 📈 401k match & profit sharing
- 🏖️ Paid Vacation and holidays
- 😌 Medical, dental, and vision benefits
- 👀 Much more...
