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Manager, Quality Assurance
at BREG Incorporated
We currently have a full-time opening for a Manager, Quality Assurance in Grand Prairie, TX. If you are looking for a fast paced environment where you can make a difference every day, then this is the opportunity for you! This position is responsible for managing the Quality System to ensure compliance as it relates to FDA/QSR and ISO 13485:2016 regulatory requirements. This position manages the Quality Team, including technicians involved in Receiving Inspection, In-process, Final Release and RMA activities. This position will provide direction and leadership to the organization related to component/product quality and compliance issues, report on audit findings, make recommendations for and lead and implement improvements of Quality System processes, and/or business systems; and lead and support resolution of product quality issues. This position is also responsible for maintaining the Corrective & Preventive Action System, Nonconforming Material System and developing and preparing QA metrics in support of Management Review and continuous improvement initiatives.
Your day will be very busy… you will:
- Manages development, implementation and maintenance of the Quality System and processes to ensure compliance with applicable regulatory requirements.
- Manage the day to day operations of the Receiving Inspection, in-process inspection, final release and RMA functions.
- Acts as the facility technical expert for all regulations (FDA, ISO, etc) and provide guidance and direction regarding compliance to the management team and facility.
- Mentor and develop direct reports with regards to understanding of QSR, ISO 13485, and applicable regulations.
- May prepare, support and participate in regulatory agency audits and inspections.
- Participates in and manages the Internal Audit program, covering all aspects of the ISO13485 and applicable FDA regulations.
- Develops and implements improvements to Quality systems and processes in compliance with corporate policies, FDA QSR, ISO 13485 and other quality requirements, regulations and standards.
- Develops quality metrics. Performs data analysis and prepares metrics in support of Quality Management Review.
- Maintains the Corrective and Preventative Action System and related database. Coordinates and facilitates the activities of the Corrective Action Board (CAB).
- Maintains the Nonconforming Material Review and related databases. Coordinates and facilitates the activities of the Material Review Board (MRB) to ensure timely resolution and appropriate documentation.
- Participates in cross functional project teams to support the release of new products and related projects from a Quality perspective.
- Creates/revises standard operating procedures and other internal quality system related documents.
- Perform, support and/or coordinate product failure investigation, corrective and preventive action, quality improvement projects, and supplier audits.
- May support the complaint investigation process to ensure timely evaluation and resolution of product quality issues.
- May participate in Breg’s accreditation as a Home Medical Device Retailer in support of Medicare billing program.
- Manages departmental expenses to ensure compliance with departmental budget.
- Leadership responsibilities include the selection, development, performance management and continuous recalibration of staff; ensures appropriate staffing levels and resource allocation; performs administrative tasks associated with timekeeping, pay, performance, policy administration and other matters related to employment.
The right person to join our team is...
Demonstrates ownership and accountability; demonstrates the ability to plan, execute, control and deliver, and to communicate effectively both written and verbal; lead and influence others effectively.
What your background will be:
- BS in business administration, engineering or related major is required. MBA or Advanced Quality or Regulatory certification preferred. Equivalent combination of education and experience may qualify. Candidate must have a minimum of 7 years of managing a quality department.
Other specific experience required or preferred includes:
- Strong working knowledge of ISO 13485:2003, QSR and other related standards
- Experience in a regulated industry. Medical device manufacturing of FDA Class 1 & 2 devices preferred.
- Manufacturing experience to include Lean Manufacturing and Continuous Improvement. Experience with Lean Six Sigma is highly desirable.
- Knowledge, experience and proven adaptability with different manufacturing disciplines
- Root Cause Analysis skills and methods
- Successful experience product development quality and in integrating new products into the manufacturing process
- Adaptability and resourcefulness to roll-up sleeves and multi-task in order to thrive in an aggressive growth company.
- Excellent knowledge of applicable foreign and domestic regulations and must have experience in implementing, improving and maintaining Quality Management Systems and other regulatory requirements
- Oracle, or similar ERP experience. Skilled with Microsoft Windows, Outlook, Word, Excel is required.
For four consecutive years Breg has been awarded The National Business Research Institute (NBRI) Circle of Excellence Award for employee engagement AND Breg has been awarded as one of the Best Places to work in San Diego in 2014 by “The U-T San Diego Top Workplaces”
If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the ‘Careers’ section.
Breg is an Equal Employment Opportunity Employer and dedicated to a diverse work force and Drug Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.