- Class III Global Medical Device Manufacturer
- Remote Opportunity
About Our Client
Our client is a leading global medical device manufacturer that has been in business for over 30 years. They have continued to grow throughout COVID and offer one of the most unique opportunities in the market. They seek a Senior Quality Specialist that will play an integral part in their Global Compliance team.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Senior Quality Specialist will be responsible for the following;
- Oversight for training requirements, including developing training plans which will facilitate consistent and thorough knowledge base.
- Management of Third-Party Agreement activities
- Responsible for current complaint handling processes to ensure day to day operations meet regulatory requirements and guidances.
- Responsible for monitoring the performance (timeliness, output volumes), quality, and compliance to SOPs and Quality Policies for assigned employees/contracted vendors.
- Support and participate in internal and external audits.
- Leads activities related to initiation and completion of department Non-Conformances, and thorough and accurate CAPA investigations Work on special projects as they arise.
The Successful Applicant
- Bachelor of Science degree in engineering
- Knowledge of regulatory requirements: quality systems regulations (FDA 21 CFR: 820, 803), EU MDD/MDR and other international regulations and standards
- American Society for Quality (ASQ) or Six Sigma Green Belt / Black Belt certification
- Organization, prioritization and familiarity with working in a regulated industry setting
- Able to consistently meet deadlines despite high volume.
What's on Offer
- Competitive base salary between $85,000-$100,000, depending on experience and skills
- 5% Annual bonus
- 5% 401k match
- Medical, dental, life, ST & LT Disability
- 15 PTO Days + 10 Paid holidays
- Flexibility, remote opportunity through summer