Quality Control Supervisor

Posted 2 Days Ago
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Irvine, CA
Senior level
Healthtech • Manufacturing
The Role
The Quality Control Supervisor is responsible for overseeing the day-to-day operations of quality control and production personnel, ensuring compliance with quality specifications, safety standards, and manufacturing regulations. This role involves monitoring production output, training staff, conducting audits, and collaborating with engineers and regulatory bodies.
Summary Generated by Built In

About Balt  

Our purpose is to improve the lives of 150,000 patients in 2026.  

 Our story 

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. 

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. 

 Why Join Balt? Join a passionate team, dedicated to making a difference.  

  1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  
  2. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  
  3. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  
  4. No matter the country, we take care of you.  

Would you like to be part of our story? Don't hesitate, come and join us! 

 About this opportunity – Quality Control Supervisor

Description

The Quality Control Supervisor will be accountable for the performance of assigned operational areas against shared business objectives such as safety, quality, compliance, production output, overall production costs, and overall quality testing costs. The Quality Control supervisor will ensure conformity with quality specifications and ensure that finished products conform to government and company standards as well as good manufacturing practices regulations.

Job Responsibilities

  • Coordinates the day-to-day activities of a team of quality and production personnel to ensure that manufacturing operations run according to established production specifications and schedules, volume, cost and quality standards.
  • Monitors the quality and volume of output and adjust tasks, timing, equipment set-up or inputs so that production specifications are met and resources are used efficiently.
  • Supervises staff to ensure that all quality and production tasks are performed and all machines and equipment operated safely.
  • Trains new workers in the organization's operating procedures and standards.
  • Provides quality information for manufacturing by compiling, initiating, sorting, and analyzing production performance records and data. answering questions and responding to requests
  • Perform regular daily audits of key processes to ensure optimum process performance.
  • Ensures production is performed in full compliance with the Quality System and all procedural requirements.
  • Ensure fair and consistent application of company and departmental policies and practices. Works with personnel to resolve employee relations issues and concerns; involves HR when needed.
  • Actively participates and supports continuous improvement activities.
  • Leads activities to communicate and maintain adherence to company policies, quality standards, safety standards, and good manufacturing practices.
  • Provide ongoing feedback and mentoring of Quality and Manufacturing personnel, including writing and delivery of annual performance reviews.
  • Support investigations associated with non-conformances.
  • Work with engineers to determine appropriate support activities for non-conforming goods and new products.
  • Interface with the FDA, state agencies, and notified bodies during certification, surveillance and routine ISO audits.
  • Participate in cross-functional Quality Objective teams.

 

Qualification Requirements

  • Bachelor’s degree preferred in technical discipline. In lieu of a degree, a combination of a high school diploma and work experience may be considered per management discretion.
  • Minimum 5 years in quality or manufacturing supervisor role for medical device manufacturing.
  • Use of video inspection equipment and other inspection tools is desirable
  • Understanding of inspection sampling plans.

 

Skills

  • Strong leadership and collaboration skills with ability to work independently.
  • Strong communications skills, oral and written.
  • Excellent organization, prioritization, and time management skills.
  • Excellent analytical and problem-solving skills using applicable problem-solving tools.
  • Ability to multi-task and manage competing priorities.
  • Possess high degree of initiative and self-motivation.
  • Must adhere and enforce company code of conduct and safety requirements
  • Keen attention to detail when reviewing documentation and processes.
  • Comfortable with working independently and cross-functionally as part of a team.
  • Comfortable with communicating with a wide range of stakeholders from production, regulatory, management, suppliers, and others.
  • Inspection techniques, understanding technical documentation including mechanical drawings.
  • Reading technical documentation.
  • Working in controlled environments (cleanroom).
  • Good intra-personal skills.
  • Qinspection and testing.
  • Knowledge of Six Sigma/Lean tools application in manufacturing.
  • Knowledge of computer applications required (i.e., Microsoft Project, Word, Excel, PowerPoint, Visio).

 

Highly Desired Qualifications:

  • Familiar with catheters, coils, and/or stents device manufacturing processes and equipment.
  • Exposure to Test Method Validation and/or Measurement System Analysis such as Gage R&Rs and attribute agreement analysis.


Work Environment

  • Working conditions are normal for an office environment.
  • Extended computer usage.
  • Standard PPE gowning requirement for cleanroom activities is required.
  • Moderate lifting.
  • Extended periods of walking or standing.
  • Microscope usage.


The above information on this description have been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.


Balt Group is an Equal Employment Opportunity employer.


More information please go to www.baltgroup.com 


Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

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The Company
HQ: Boston, Massachusetts
397 Employees
On-site Workplace
Year Founded: 1977

What We Do

We are Balt.

Physician-inspired innovations. Patient-focused solutions.

For more than 45 years, Balt has been leading the way – collaborating with physicians and institutions to develop elegant neurovascular solutions. As the premier global neurovascular platform, always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We introduced the first neurovascular intervention device in 1977. Now, we offer the world’s broadest portfolio of medical devices for ischemic and hemorrhagic stroke, as well as devices for peripheral embolization.

In 2015, we embarked on an ambitious journey and more than quintupled our revenue and workforce, and that was only the beginning. Now, the Balt family includes more than 700 talented team members at 13 sites in 11 countries around the world.

Be a part of our future: www.baltgroup.com

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