Midmark Corporation · 9 hours ago
Quality Assurance Specialist II
Versailles, OH
Full-time
Onsite
Entry, Mid Level
2+ years expMidmark Corporation is a company transforming healthcare experiences through innovative design within the medical, dental, and animal health environments. They are seeking a Quality Assurance Specialist II to administer and maintain regulated Quality Assurance processes in accordance with FDA and ISO regulations, ensuring quality management systems are upheld and improved.
Health CareManufacturingMedical Device
Responsibilities
May assist with various Quality System process including, but not limited to: Engineering Change Orders (ECO)’s, Document Control reviews and approvals as well as Change Control Board (CCB)
May mentor teammates on the doc control system, ECO process and software programs
Maintaining Quality Record Management procedure, work instruction and forms for processes
Assist with various departments to create and maintain work instructions, quality forms, logs, test reports/test results and other misc. documents related to the quality management system
Assist all internal customers in gathering raw data for trending. Ensure updates to presentations are done in a timely manner
Assist in internal audits of the quality management systems. FDA, ISO, and other regulatory audits
Assist in the development and oversight of internal audit schedule and plan
Identify and assists in quality system process improvements to streamline processes or to adjust to changes in quality and regulatory requirements
May review complaints for required information and clarity
Recognize if complaints meet requirements for mandatory/voluntary reporting to notified bodies
Determine if complaint has previously been addressed according to relevant complaint & history
Analyze quality data and trending for presentation & discussion.Examples include CAPA, ECO and internal audit process metrics.Assist instablishing recommended targets and goals for applicable metrics
Identify and implement complaint process improvements streamline processes in quality or to adjust to changes in quality and regulatory requirements
Leads CAPAs/MIs and the CAPA process. This includes development of CAPA Review Board
Trains teammates on the CAPA/MI process
Support quality initiatives around risk analysis and risk management
Review service records, identify potential customer complaints
Support nonconformity report (NCMR) closure
Support external audits in front room, back room including as a backroom lead or as scribe, including necessary training for auditing
Qualification
Required
Associate degree (A.A.) from a two-year college or university
Minimum of two years' related experience and/or training
Equivalent combination of education and experience
Successfully completed ISO Internal Auditor training
Excellent organizational skills
High attention to detail
Ability to multitask
Strong writing, grammar and proofreading abilities
Ability to effectively present information in one-on-one and small groups
ISO Internal Auditor Training/Certification
Project management experience
Preferred
Familiarity with ISO 13485 and 21 CFR Part 820 requirements impacting the site they lead
Company
Midmark Corporation
Midmark Corp manufactures and supplies medical, dental, and animal health products.
1001-5000 employees
H1B Sponsorship
Midmark Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (5)
2023 (1)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Susan Martin
Vice President & Midmark RTLS
Recent News
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