Regulatory Affairs/Quality Assurance Director

DDS Lab - Tampa, FL (30+ days ago)3.0


Regulatory Affairs/Quality Assurance (RA/QA) Director

Overview

The RA/QA Director will be responsible for developing the QMS (Quality Management System) for DDS Lab Tampa operation toward compliance and/or registration to the medical device quality standards that become important for DDS Lab’s business including ISO 13485, 21 CFR part 820 (Good Manufacturing Practices) and Canada’s MDSAP. In so doing, there will be specific emphasis placed on customer facing quality systems like complaint handling so that complaints are recorded, root cause and corrective actions are driven throughout the DDS Lab in Tampa and Shenzhen, China and the communication loop is closed with the DDS customer(s).

The RA/QA Director is also responsible for establishing and reporting on KPIs and driving process improvement based on these metrics, performing appropriate root cause analysis and driving the improvement associated with these KPIs across all DDS Lab departments. Examples of quality KPIs are Remakes and Repairs, Customer Complaints, Error Tracking, PL Cases, On-Time Ship.

When and if needed the RA/QA Director will also be responsible to lead efforts for 510K clearance on new product(s) that DDS Lab may want to bring to the US and Canadian market(s). Position will report directly to the VP of Information Technology.

Essential Duties and Responsibilities

  • Lead process improvement and documentation efforts for all Quality Management Systems for compliance with appropriate quality standards.
  • Take ownership for the Customer Complaint system which includes the recording, evaluation and analysis of complaints, corrective actions and closing the communication reporting loop with customers.
  • Establish dashboard of quality KPIs, posting and/or distributing these so all employees have visibility to these KPIs.
  • Establish quality improvement goals to drive needed improvement. Organize periodic quality review meetings to drive support for goal achievement.
  • Improve reporting for Remake and Repair KPIs.
  • Assume ownership for DDS Lab controlled documents and lead efforts to make changes to SOPs and work instructions required to drive improvement. Utilize these documents to train the Tampa work force.
  • Interface with Sales, Finance, Product Management, Operations and Human Resources to collect and share customer and product intel, scheduling routine meetings and collaborating on projects related to quality or customer complaint initiatives.
  • Develop production audit capabilities for appropriate functional areas of the Tampa operation. Retrain Tampa employees as needed to improve efficiency and quality.
  • Create and maintain company quality documentation, such as quality manuals, quality procedures, SOPs and training guides, etc.
  • Function as the quality liaison for DDS Lab customers, Tampa and Shenzhen organizations. Ensure that quality requirements and procedures are communicated and implemented in both DDS locations and, where appropriate, with third party suppliers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills and Abilities

  • Ability to learn complex IT systems, manage and analyze data. Ability to make compelling, analytical presentations in PowerPoint.
  • Ability to process map established processes and perform process engineering improvements to drive improvement and efficiency.
  • Ability to lead effective problem solving team across many functional areas of DDS Lab including Sales, Marketing, Account Management, suppliers and Operations.
  • Able to lead a process with little outside direction, taking initiative to build reports, run analysis, contact customers, as well as other tasks that aide in staying abreast of the current state of complaints
  • Ability to communicate resolutions to complex issues in an effective manner to customers and stake holders.
  • Basic knowledge of quality principles
  • Strong technical writing/document writing skills
  • Experience with QMS, corrective action documentation processes & procedures
  • Ability to multi-task, use personal judgment and utilize strong decision making skills
  • Collaborative, able to bring employees at all levels of the organization together for projects

Qualifications (Experience, Education, Licensure, Certification)

  • Bachelor’s degree or equivalent experience
  • Five plus years’ experience in Regulatory and quality systems in an FDA regulated medical device industry
  • Experience in support of a proprietary compliant system and management dashboard
  • Four years’ people management experience; track record of building and leading high performance teams
  • Working knowledge of Quality Management Systems – GMP ,21 CFR Part 11, ISO 9001/13485, ISO 14971, in manufacturing environments

About DDS Lab

DDS Lab is fast growing multinational healthcare company based in Tampa, FL. DDS Lab provides over 400 different medical devices for dental service organizations, mid-size group dental practices and sole practitioner dentists across the United States. The company's mission is to make a difference in the lives of patients with quality solutions that enable dentists to create healthy smiles. We believe having a talented team of professionals helps us achieve this goal.

Our benefits program has a robust offering of solutions designed to meet the health and wellness needs of our employees and their loved ones. More information about our products, services, benefits, and team is found on www.ddslab.com.

EOE/DFW

Job Type: Full-time

Experience:

  • management: 1 year (Preferred)
  • medical device industry: 1 year (Required)