Quality Systems Specialist
About The Position
The purpose of the Quality Systems Specialist is to assist the QA & RA Manager in ensuring overall compliance and effectiveness of the quality system. Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.
Requirements
- Four-year degree from accredited college/ university in Business or Scientific discipline, or experience equivalent
- Three or more years’ experience in the medical device or FDA regulated field.
- Three or more years of auditing experience
- ISO 13485:2016 Lead Auditor certification or equivalent preferred
- A self-starter who thrives in a fast-paced environment
- A quick learner who is always ready to gain depth of knowledge in manufacturing processes
- A reliable individual who knows the importance of showing up when it counts
- Someone who accept assignments with an open, cooperative, positive and team-oriented approach
- Someone who is able to plan and execute plans across teams
- An effective communicator, both written and verbal
Responsibilities
- Manage the audit program for internal and external audits.
- Support management during third-party audits/inspections (preparation, execution, and responses).
- Conduct supplier audits when deemed necessary.
- Oversee supplier quality performance.
- Ensure QMS documents are robust and in compliance with ISO 13485 and 21 CFR 820.
- Provide recommendations for improvements to the overall system and drive continuous improvement.
- Drive and evaluate root cause analysis, corrective action plans, and effectiveness checks.
- Co-ordinate the collection, preparation, and presentation of assigned management review inputs.
- Maintain knowledge of quality standards and regulations including proposed and final rules.
- Coach and mentor as necessary to ensure skill sets are developed across employees.
- Assist in customer complaint handling as necessary.
- Performs other duties as assigned or required.
- For those divisions where the Quality Systems Specialist acts as the Document Control Specialist, the responsibilities of the Document Control Specialist job description also apply to the Quality Systems Specialist.
Benefits
- Competitive compensation and benefits package
- Comprehensive medical, dental, and vision insurance
- Paid vacation and 10 observed paid holidays per year
- Employer funded Basic Life and AD&D insurance
- Employer funded STD and LTD insurance
- Tuition reimbursement
- Great 401(k) with company match
- Generous employee referral bonus program
- Working for a thriving, performance-based company that values promoting from within and career advancement
- Temperature controlled environment
- Community involvement investing and giving back to the community
- Additional free resources such as travel assistance, EAP, etc.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
