Resume for Joan Rubendall

1. Joan Rubendall
Quality and Regulatory Affairs Professional
jhrubendall@gmail.com - 941.232.4549
• Professional experience in quality assurance and regulatory affairs management.
• Experienced interfacing with regulatory agencies and strong working knowledge of FDA, EU, CPSC and ISO
requirements.
• Able to drive change, champion new activities and manage implementation effectively.
• Results-oriented, ethical leader with a proven track record.
Willing to relocate: Anywhere
Authorized to work in the US for any employer
WORK EXPERIENCE
VP, Quality
TERVIS TUMBLER COMPANY - Venice, FL - 2013 to Present
* Responsible for quality, product compliance and safety for Tervis brand products, food, toys, and other
hardlines and softlines sold through various business channels in the US, Canada, Mexico and Europe.
* Responsible for executing the corporate strategy and developing leadership talent.
* Recognized as the company's Change Management Leader in 2014.
* Implemented quality processes and a supplier quality management program achieving 100% on time new
product launches and reduced incoming product defects by over 70%.
* Manage a team of Quality Engineers, quality auditors and laboratory technicians responsible for new product
APQP, supplier quality, product testing, metrology, operational quality and document control.
* Oversee the preparation of product specifications, product certifications, risk assessments, technical files,
declarations of conformity and other regulatory and customer required documentation.
* Work closely with Sales, Marketing and New Product Development to design and launch new products.
* Principal interface with CPSC, FDA and other regulatory agencies to ensure compliance requirements are
implemented and followed.
* Member of various company management committees responsible for social accountability, business
continuity and regulatory affairs.
VP, Regulatory Affairs
ASO CORPORATION - Sarasota, FL - 2008 to 2013
Sr. Director, Quality Assurance & Regulatory Affairs
- 1999 to 2008
Manager, Quality Assurance & Regulatory Affairs
- 1991 to 1999
* Held various roles of incremental responsibility in quality and regulatory over a 22 year period.
* Led global quality system and regulatory compliance at ASO's medical device, OTC pharmaceutical and
sterilization sites worldwide.
* Member of the executive team responsible for developing the company's corporate budget, short and long-
term business strategy and quality goals and objectives.
* Worked with new product development teams to establish product design requirements and compile design
history files.

2. * Responsible for providing regulatory guidance to Sales, Marketing and Project Managers to drive business
strategy and decisions.
* Championed quality and regulatory initiatives to ensure consistency, compliance and good manufacturing
practices were maintained throughout the organization.
* Managed project and implementation teams to achieve ISO 13485, MDD and CMDCAS certification at
manufacturing sites in the US, Mexico and Philippines.
* Responsible for preparation of 510(k) submissions, Technical Files and all other regulatory documentation
and communication.
* Interfaced regularly with FDA and other regulatory agencies to ensure compliance requirements were
implemented within the organization.
* Managed supplier quality assurance, social compliance, document control, complaints and recall programs.
* Served as a corporate auditor and performed FDA 820 & 210/211, CMDCAS, MDD and ISO 13485 audits
for the company globally.
Manager, Quality Assurance
Land-O-Sun/Pet Dairies, Inc - Saint Petersburg, FL - 1989 to 1991
* Managed quality inspectors and an analytical laboratory for inspection, testing and release of component
materials and finished products.
* Performed plant GMP training and inspections to ensure FDA compliance.
* Participated in FDA and local health inspections.
* Managed all document control functions including writing SOPs, test methods and compiling MSDS
information.
* Prepared and managed the quality department budget and expenditures.
* Handled customer complaints and complaints trending.
* Chaired a continuous improvement committee.
Corporate Quality Assurance Manager
Harris-Teeter Supermarkets, Inc - Charlotte, NC - 1985 to 1989
* Developed a corporate private label qualification program for a wide array of food, beverage and consumer
products.
* Interfaced with suppliers and executive management to develop products for the Harris Teeter brand that
met the company's quality standards and regulatory requirements.
* Established a supplier approval program to qualify suppliers. Performed supplier audits.
* Worked with local, state and federal regulatory agencies to coordinate store and manufacturing site
inspections.
* Worked with the FDA and local regulatory agencies in conducting product recalls.
* Developed in-store sanitation inspection program and performed employee training for all store and
warehouse employees.
* Responsible for developing and implementing quality assurance systems and training quality staff at Harris
Teeter's dairy and bakery manufacturing operations.
EDUCATION
BS in Food Science
North Carolina State University - Raleigh, NC

3. SKILLS
ISO 13485, CE Marking, 510(k)s, FDA Inspections, Recalls, Quality Auditing, Management Representative,
Customer Complaints/Customer Service