Regulatory Affairs and Quality Assurance Specialist II
Myrtle Beach, SC
TSO3 is a publicly traded company listed on the Toronto Stock Exchange (TOS), with offices in Québec City and Myrtle Beach, SC. Its activities cover sales, maintenance, production, research, development, and the granting of licenses of sterilization processes, accessories and related consumables for heat-sensitive medical devices. The technology has a combination of unique features in low temperature sterilization industry, which advantageously position it against the competition in this fast-growing sector. In December 2014, TSO3 has received approval from the Food and Drug Administration (FDA) for the commercialization in the US of its new STERIZONE® VP4 Sterilizers.
Join a team dedicated to Create and Deliver the New Standard of Care in Sterile ReprocessingTM
To support its current operations and future growth, TSO3 is seeking to hire a Regulatory Affairs and Quality Assurance Specialist II in Myrtle Beach, SC.
Under the supervision of the Regulatory Affairs and Quality Assurance Director, the incumbent will be responsible for the conformity and maintenance of the quality system. He will assure compliance to the standards ISO 9001, ISO 13485, EN 46001 and Quality System Regulations (QSR). He will also manage all quality and regulatory aspects of US operations.
- Establish and maintain a quality system in the US adapted to the medical equipment sector and meeting the requirements of FDA, Health Canada, the European Community (EC) and eventually, other identified countries for the marketing of the products developed by the Company.
- Provide training for staff concerning quality assurance and regulatory affairs
- Participate, as required, in the development of design requirements of new products and provide guidelines to designers on how to document the product design elements.
- Keep up-to-date of all laws and/or standards applicable to the company’s US operations, and coordinate activities to obtain conformity and/or product certification
- Support the Director, QA-RA in the development necessary documentation to obtain legal authorization for the marketing of Company products for targeted markets
- Follow the customer complaints, determine if a mandatory declaration of the problem is required and communicate incidents to concerned regulatory organizations in compliance with applicable legal requirements
- Revise documents and publications of the Company
- Bachelor’s degree in Mechanical or Industrial Engineering
- Experience: 3-5 years of experience, in Regulatory Affairs or Regulatory Affairs /Quality Assurance field combined, RAC certificate an asset
- Working knowledge of risk analysis techniques such as FMEA, FTA, HAZOP
- Experience in a manufacturing setting (process study, SPC) an asset
- Organized, self-directed, rigorous, good problem solver and team oriented.
- Ability to synthesize and simplify processes and give training
- Management abilities
- Ability to define clear user, regulatory and technical requirements addressing stakeholders needs
- Ability to link information from various sources and/or disciplines
- International registration experience preferred.
- Must be able to travel internationally
Many benefits await you
- Competitive salary
- Full group medical, dental and vision insurance Stock purchase plan
- 401k with Company match
- Additional benefits
We thank you for your interest in TSO3. Please take note that we only communicate with the candidates retained for an interview.
TSO3 is an equal opportunity employer.
How to apply?
Send us your resume by:
Fax: (418) 653-5726
2505, avenue Dalton, Québec (Québec)
CANADA G1P 3S5