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Quality Manager

4 months ago

Irvine, California, United States Balt Full time

About Balt

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

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 story? Don't hesitate and come and join us.

About this opportunity - Operations Quality Engineer Manager Next>

Description:

  • The Operations Quality Engineer Manager reports to Balt USA's Quality Director and has overall responsibility for the site Production and Process Control This includes Line Quality Engineering, Quality Control, Calibration Management, Labeling System, and Training System.
  • This onsite role is responsible for the development, implementation, maintenance, and sustenance of quality management systems supporting quality operations for Balt USA. The position will ensure compliance with, but not limited to, ISO 13845, 21 CFR Part 820, MDD 93/42/EEC, MDR 2017/45, and MDSAP program.
  • This role works in close cooperation with Site Leaders, the Global QS Director and other site SMEs on ensuring full compliance on the site production and process control processes and is accountable to maintain assigned processes at the state-of-the-art level and under full compliance.
    • This role also works closely with the operations function to improve the local QMS and meet

emerging site strategy needs.

Job Responsibilities:

Management Responsibility

  • Ensure that production and process control requirements are effectively established and managed through reporting on the performance of the quality system to management as part of management review.
  • Provide inputs to the management review effort to assess the suitability and effectiveness of the quality system.
  • Develops and maintains process procedures, work instructions and key process indicators (KPIs), follows-up and addresses any unfavorable KPIs trend on assigned
  • Leads and develops the Quality Engineer team, defining their objectives and monitoring their performance regularly.
  • Responsible for ensuring smooth communication and work between the Quality Engineers and Manufacturing Engineers
  • Responsible to regularly monitor and evaluate the Quality processes through close monitoring of data and to report any negative trend and/or opportunities for improvements to site leadership team for action to be taken.

NCMR and CAPA

  • Coordinate efforts with Line Quality Engineers to complete assigned NCMR and CAPA.
  • Lead problem solving efforts for continuous improvement requirements resulting from nonconformities.
  • Retain hands-on involvement in root cause analysis derived from identified nonconformities.

Quality Control

  • Oversee in-process, receiving inspection, and warehouse quality functions.
  • Ensure good documentation practices (GDP).
  • Coordinate the collection and analysis of statistical data.
  • Utilize manufacturing techniques and tools to support operational efficiency goals.
  • Apply GR&R concepts to control measurement and system analysis.
  • Ensure that the site metrology activity is maintained compliant with applicable standard/ procedure requirements.

Labeling

  • Responsible for the management of the Labeling Specialist in the creation, management, and change control process.
  • Labeling is responsible for the overall coordination, development, and execution of labeling for commercialized and new product development products.

Training

  • Responsible for the management of the Training Specialist to ensure training is set up and efficiently implemented on assigned processes across the site.
  • Maintain training compliance goal.

Continuous Improvement and Compliance

  • Support quality engineering through continuous improvement projects and/or remediation activities.
  • Identifies opportunities for improvements and simplifications for assigned process. Actively participates in meetings with other site SMEs to share these opportunities.
  • Recommend measures to improve production methods, employees' performance, quality, and product delivery.
  • Utilize lean manufacturing techniques and tools to drive operational efficiencies.
  • Participate in problem solving and related improvement activities.

Talent Management

  • Manage personnel in processing of change orders supporting continuous improvement initiative, NCMR, and CAPA.
  • Manage personnel in the coordination of other quality system activities.
  • Ensure employee expectations are clearly communicated.
  • Provide personnel performance feedback.
  • Perform other duties as required or directed by senior management.

Qualification Requirements:

  • Interacts with all levels of management representing Regulatory Affairs, Operations, Engineering, Clinical/Medical Affairs, R&D, Customer Service, HR, Sales and Marketing.
  • Must adhere to the Balt USA's code of conduct and core values.
  • Must follow designated safety rules and regulations.
  • Have excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
  • Professional certification(s), such as from ASQ or auditing body, is an enhancement.

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.
  • Ability to multi-task and manage competing priorities.
  • Ability to manage assignments complex in nature requiring sound judgment.
  • Possess a high degree of initiative and self-motivation.
  • Knowledge of statistical process control and software, such as Minitab.
  • Computer experience with ERP systems and MS Office program suite.
  • Understanding of problem-solving tools such as cause-and-effect diagram, affinity diagram, 5 whys, check sheets, and flowcharts.
  • Understand risk management principles and procedure to apply corrective action decisions.
  • Understand application of SPC and control charts.
  • Must adhere to and enforce company code of conduct and safety requirements.

Pre-requisites / Job Experience:

  • Minimum BS degree from an accredited four-year college or university.
  • 5+ years of work experience demonstrating strong understanding of manufacturing environment and quality control inspection.
  • Experience managing a diverse workforce with technical and non-technical aptitudes.
  • Technical competencies including statistical analysis, validation experience, and measurement system analysis.
  • Has knowledge for the application of systematic problem-solving
  • Working relationships with focus on interdepartmental support.

Physical Requirements:

  • Extended periods of sitting or speaking.
  • Light lifting.
  • Moderate to heavy computer use.
  • Must adhere to the company's safety practices by performing work safely and in accordance with established standards.
  • Able to work in a fast-paced quality–oriented manufacturing environment.

Work Environment:

Working conditions are in an office environment and production ISO cleanroom.

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities. tasks, and duties, and does not limit the assignment of additional duties for this position.

Balt Group is an Equal Employment Opportunity employer.

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