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.

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• 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!

Description

About this opportunity – Quality Systems Manager

• Position has responsibility for Balt USA’s Irvine operation for quality system processes: Document Control, Training, Audits, NCMR, CAPA, Supplier Quality supported by the data analysis processes.
• Assure compliance and progress toward Balt’s established goals through developing and enforcing quality management systems and procedures; understanding, communicating, and assuring customer expectations; building in quality to assure consistent quality processes and management of staff.
• Act as the management representative backup for Balt USA.
• Work in close cooperation with other quality management, the Global QS Director, and other site’s quality system SMEs to ensure compliance on the site management control processes.
• Lead and develop the Quality System Engineer team, defining their objectives and monitoring their performance regularly.
• Identify opportunities for improvements and simplifications for assigned processes. Actively participates in meetings with other site SMEs to share these opportunities.
• Responsible for the management of internal and external audit processes, from scheduling to closing audits through ensuring efficient follow-up on any non-conformities.
• Possesses a sense of urgency to accomplish change order tasks and supports projects in a process-oriented manner.
• Responsible to regularly monitor and evaluate the quality system performance - for document control, nonconformances, CAPAs, training, audits, and supplier quality –through data analysis and to report any negative trend to site leadership team for action to be taken.
  
  

Job Responsibilities

• Develop process procedures, work instructions and key process indicators (KPIs) and follow up and addresses any unfavorable KPIs trend on assigned processes.
• Coordinate and facilitate implementation of process improvement projects across the site to standardize and simplify it and obtain cost savings working in close cooperation with other site Management Control SMEs, site management, and the global management.
• Support the site Quality Management in audits for assigned process, preparing, and acting as follow up to internal and external audits.
• Facilitate management review and ensures requirements and actions agreed during management reviews are compliantly and efficiently implemented.
• Provide daily quality decisions and direction on document control matters and responsible for authoring, reviewing and approving procedures.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues on his/her assigned process.
• Ensure close monitoring and follow-up on any NCMR and CAPA raised against the assigned process within the site, from initiation to fully documented closure.
• Ensure all quality system documentation is processed and archived appropriately through QCBD or another designated eQMS. Quality System documents include, but are not limited to, manuals, procedures, instructions, forms and the applicable standards.
• Ensures training is set up and efficiently implemented on assigned processes across the site.
• Provides applicable quality system training to new employees and conducts ongoing refresher training for existing employees.
• Set up regular process meetings to identify opportunities.
• Effectively communicate performance goals and expectations with employees to help in their continuous improvement.
• Interact with all levels of management from technical personnel and cross functionally.
• Work with regulatory agencies as required.
• Work in close cooperation with other process SMEs at Balt.
  
  

Qualification Requirements

• College degree preferably in Quality, Engineering or associated fields required (preferably mechanical)
• Experience (Minimum 8 years) in working with medical device manufacturers or other equivalent combination of education and experience; experience to be applicable in Management Controls within a certified Quality Management System.
• Knowledge of the Medical Devices Directive 93/42/EEC, the MDR 2017/45, main Medical Devices standards: ISO 13485, ISO 14971, and FDA regulations.
• Knowledge of MDSAP program and FDA Quality System Regulation.
• Strong organization, written communication, and planning skills. Proven ability to successfully direct people and projects
  
  

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.
• Reading technical documentation.
• Working in controlled environments (cleanroom).
• Good intra-personal skills.
• Knowledge of Six Sigma/Lean tools application in manufacturing is favorable.
• 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.

Pay Range

$140,000—$160,000 USD