Quality Systems Specialist

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.The purpose of the Quality Systems Specialist is to assist the QA & RA Manager in ensuring overall compliance and effectiveness of the quality system.What You’ll Do: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.What You’ll Need:Four-year degree from accredited college/ university in Business or Scientific discipline, or experience equivalentThree 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 preferredWhat You Won’t Do:Feel stuck – we offer great opportunities to advance and learnGet bored – we make a high variety of products, so no day is the sameFeel like a number – we’re a close-knit bunch and always have each other’s backs Who You Are:A self-starter who thrives in a fast-paced environmentA quick learner who is always ready to gain depth of knowledge in manufacturing processesA reliable individual who knows the importance of showing up when it countsSomeone who accept assignments with an open, cooperative, positive and team-oriented approachSomeone who is able to plan and execute plans across teamsAn effective communicator, both written and verbalWhat You’ll Enjoy:Competitive compensation and benefits packageComprehensive medical, dental, and vision insurancePaid vacation and 10 observed paid holidays per yearEmployer funded Basic Life and AD&D insuranceEmployer funded STD and LTD insuranceTuition reimbursementGreat 401(k) with company matchGenerous employee referral bonus programWorking for a thriving, performance-based company that values promoting from within and career advancementTemperature controlled environmentCommunity involvement investing and giving back to the communityAdditional free resources such as travel assistance, EAP, etc.Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.