Job Description
CDB Corporation is a world leading Original Equipment Manufacturer (OEM) specializing in the development and production of innovative, aesthetic orthodontic brackets. Based on forward thinking technology and a commitment to excellence, CDB is dedicated to delivering custom solutions to its customers worldwide. In compliance with ISO 13485, FDA (USA), PAL (Japan), and CE (Europe), CDB also holds several patents for bracket designs, features, and production methods.
Job Purpose: Responsible for managing quality assurance and developing and implementing quality management procedures and systems for all the company's products. This position is also responsible for managing product regulatory compliance as well as managing the Quality Inspection team.
Essential Duties and Responsibilities:
* Manage Quality Assurance by developing and implementing quality management policies, procedures, and systems for all of the products and by continually improving the Quality Assurance system
* Monitoring product conformity to specifications and certifying and issuing the certificate of conformity
* Responsible for all internal product testing
* Responsible for complaint management. Finding and analyzing root causes through a cross functional team approach and submitting timely reports to the customer to close and taking corrective and preventative action for nonconforming products
* Responsible for implementing internal audit plan
* Spearheading continuous quality improvements to maximize production yields
* Ensuring that all departments are in compliance with all applicable standards including FDA, ISO 13485, and European Medical Device Directive
* Conferring with management to identify and correct potential areas of non-compliance and anticipate future compliance requirements
* Acting as liaison between the company and Federal government regulators, preparing filings and reporting
* Developing corrective action plans for audits, citations, notices of violation, and by registering materials with the U.S. government, as necessary.
* Manage approximately 9 employees in the QC Department
Required Skills & Experience
* 3-5yrs QA/Compliance related work and supervisory experience in a manufacturing environment
* Knowledge of ISO 13485, QSR 21 CFR Part 820 regulatory requirements
* Self-motivated, energetic, dependable, honest, and thorough. A versatile, self-starter with a positive attitude, who is cautiously assertive; willing to put in extra effort and hours as needed.
* Ability to modulate with a dynamic workload: From heavy multi-tasking during peak workloads - to very focused, detail-oriented work during critical projects
* Strong project management, organizational, and communication skills are required.
* Team attitude; eager to cooperate with others with exceptional interpersonal communication skills.
* Ability to positively motivate individuals and teams to meet or exceed project expectations. Provide coaching as needed to improve productivity and quality performance of QC employees
* Proficient computer skills
Nice to Have Skills & Experience
* BS/BA degree preferred
* 5 years of ISO 13485
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.