QUALITY ASSURANCE SPECIALIST
Reports to : Director, Operations
Status : Exempt
Hours : M-F, Overtime as Needed
Travel : < 5%
POSITION SUMMARY:
The Quality Assurance Specialist uses a highly collaborative approach to champion total quality within First Aid Only. He/she is demonstrates a strong commitment to driving continuous improvement, open communication, and results-orientation within the quality profession.
The successful incumbent will identify and recommend quality initiatives and activities that are consistent with the corporate mission and strategic goals. He/she will identify and drive the implementation of Quality and/or Document Control initiatives within the scope of the approved project, and meet all milestones for on-time delivery, budget, training and implementation, etc. The Quality Assurance Specialist role is a hands-on position that requires a strong ability to balance conceptual plans with day-to-day tactical activities in a highly dynamic, fast paced and multi-faceted environment.
The Quality Assurance Specialist is responsible for Document Control functions company-wide. He/she will administer and continually improve day-to-day Document Control functions while identifying ways to improve the processes and systems. The Quality Assurance Specialist will teach, facilitate and champion the adoption of Quality and Document Control initiatives and processes.
The Quality Assurance Specialist reports directly to the Director of Operations, and indirectly reports to the company CEO.
PRIMARY ROLE AND RESPONSIBILITIES:
Primary duties include, but are not limited to:
Total Quality Management: (25%)
Coach and mentor a total quality philosophy.
Operationalize a wide array of quality tools and disciplines.
Conduct in-depth root cause analyses to determine and recommend preventative actions for quality issues.
Develop and deliver training as needed.
Collaboratively identify opportunities to fine tune processes and systems.
Regulatory Compliance (FDA): (25%)
Facilitate material review meetings.
Ensure accurate, complete and compliant quality and product documentation.
Audit product documentation, such as labels and package inserts, to ensure adherence to regulatory requirements.
Maintain up-to-date knowledge of pending and current regulatory requirements, benchmarks and trends, and pro-actively communicate impact of those trends to senior leaders.
Configuration and Documentation Control: (25%)
Create and manage a rigorous system of document and configuration control
Process, distribute and maintain current document revisions.
Product Quality Assurance: (10%)
Implement and maintain a system of product assurance testing.
Set up a system of conforming and non-conforming reporting in raw material, work-in-process and finished goods.
Vendor Quality: (10%)
Prepare and report vendor quality ratings.
Personal Development: (5%)
Continue education and professional growth in business, quality, operations, and other relevant areas of study.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
Bachelors Degree in Business, Engineering or Science; or equivalent education and experience.
3 years minimum experience supporting a manufacturing environment.
5 years experience deploying and supporting quality initiatives.
3 years experience working with an electronic document control system.
Able and experienced in a highly autonomous position.
Must have experience implementing or supporting a certified ISO9000 series program.
High level of proficiency using and applying quality tools, including: using Pareto charts, SPC, root cause analysis, cause and effect diagrams, and processing mapping.
Apply ability to constructively and quickly confront and overcome barriers with external and internal contacts to delivery or service shortcomings.
Demonstrate a high professional level of oral and written communication skills across all levels of the organization.
Utilize a high level of proficiency with MS Word, PowerPoint, & Outlook.
Highly proficient using Excel, including pivot charts, macros, charting complex data.
Consistently present a professional and respectful demeanor.
Employ prompt, accurate, reliable and tactful communication skills across all levels of the organization and communication styles.
Strong ability to initiate and drive activities through to completion with minimal supervision and direction.
Highly detail oriented.
Able to work independently.
Able to periodically work overtime as needed.
Fluently read, write and speak English.
Able to work overtime as needed, including some evenings and weekends.
Able to stand, sit, and use computer/keyboard for long periods of time.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES:
10 years experience developing, designing and implementing diverse quality initiatives.
ASQ Certification.
Green or Brown Belt certification.
Familiarity with FDA requirements.
Fluency in one or more foreign languages.
Demonstrate a track record of professional development and thirst for knowledge.
Applicants who are highly qualified and are considered leaders in their discipline, work hard, champions collaboration, employs empowerment, and leads by setting an exceptional example are encouraged to apply. We are looking for an outstanding Quality Assurance Specialist who brings a track record of proven success in the Quality and Document Control disciplines.
If you meet all of the qualifications above, we'd like to hear from to you. Please submit your cover letter, resume, Employment Application, and Non-Disclosure forms. Please, no phone calls.
- Location: Vancouver, WA
- Compensation: DOE
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.