Quality Assurance Specialist II
About The Position
JOB SUMMARY: Administers and maintains Midmark Corporations’ regulated Quality Assurance processes, manual and electronic, in accordance with FDA and ISO regulation by performing the following duties. ESSSENTIAL/PRIMARY DUTIES: 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 SECONDARY DUTIES: 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.
Requirements
- This position requires an associate degree (A.A.) from a two-year college or university; and minimum of two years’ related experience and or training; or equivalent combination of education and experience
- Successfully completed ISO Internal Auditor training
- Excellent organizational skills, a high attention to detail, and ability to multitask
- Strong writing, grammar and proofreading abilities; can effectively present information in one-on-one and small groups and to other employees of the organization
- ISO Internal Auditor Training/Certification
- Project management experience
Nice To Haves
- Familiarity with ISO 13485 and 21 CFR Part 820 requirements impacting the site they lead
Responsibilities
- 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)
- Mentor teammates on the doc control system, ECO process and software programs
- Maintain 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
- 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 in establishing 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
