Midmark Corporation
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.
Essential Primary Duties
Assist with various Quality System processes including Engineering Change Orders (ECOs), Document Control reviews and approvals, as well as the Change Control Board (CCB).
Mentor teammates on the doc control system, ECO process, and software programs.
Maintain Quality Record Management procedures, work instructions, and forms for processes.
Assist various departments with creation and maintenance of work instructions, quality forms, logs, test reports/test results, and other miscellaneous documents related to the quality management system.
Assist internal customers in gathering raw data for trending and ensure timely updates to presentations.
Assist in internal audits of the quality management systems (FDA, ISO, and other regulatory audits).
Assist in the development and oversight of internal audit schedules and plans.
Identify and assist in quality system process improvements to streamline processes or 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 a complaint has previously been addressed according to relevant complaint history.
Analyze quality data and trending for presentation and discussion, including CAPA, ECO, and internal audit process metrics; assist in establishing recommended targets and goals for applicable metrics.
Identify and implement complaint process improvements to streamline processes or adjust to quality and regulatory changes.
Lead CAPAs/MIs and the CAPA process, including development of a CAPA Review Board.
Train teammates on the CAPA/MI process.
Secondary Duties
Support quality initiatives around risk analysis and risk management.
Review service records to identify potential customer complaints.
Support nonconformity report (NCMR) closure.
Support external audits in front room and back room, including serving as a backroom lead or scribe, and provide necessary training for auditing.
Education and Experience This position requires an associate degree (A.A.) from a two‑year college or university, and a minimum of two years of related experience and/or training; or an equivalent combination of education and experience. Successful completion of ISO Internal Auditor training is required.
Preferred: Familiarity with ISO 13485 and 21 CFR Part 820 requirements impacting the site they lead.
Competency / Skill Requirements
Excellent organizational skills, a high attention to detail, and the ability to multitask.
Strong writing, grammar, and proofreading abilities; able to effectively present information in one‑on‑one and small group settings and to other employees of the organization.
ISO Internal Auditor Training/Certification.
Project management experience.
Supervisory Responsibilities
N/A
Physical Demands The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this job, the teammate is regularly required to see, talk, and hear; frequently required to sit and use hands; occasionally required to reach with hands and arms; regularly must lift and/or move up to 10 pounds; and occasionally lift and/or move up to 25 pounds.
Work Environment The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this job, the teammate is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.
Additional Information This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the teammate. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Equal Employment Opportunity Midmark Equal Employment Opportunity Employer – Minorities/Females/Disabled/Veterans
EO/AA Employer Minorities/Females/Protected Veterans/Disabled
About Us Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.
Seniority Level Entry level
Employment Type Full‑time
Job Function Quality Assurance
Industries Appliances, Electrical, and Electronics Manufacturing; Industrial Machinery Manufacturing; Medical Equipment Manufacturing
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Essential Primary Duties
Assist with various Quality System processes including Engineering Change Orders (ECOs), Document Control reviews and approvals, as well as the Change Control Board (CCB).
Mentor teammates on the doc control system, ECO process, and software programs.
Maintain Quality Record Management procedures, work instructions, and forms for processes.
Assist various departments with creation and maintenance of work instructions, quality forms, logs, test reports/test results, and other miscellaneous documents related to the quality management system.
Assist internal customers in gathering raw data for trending and ensure timely updates to presentations.
Assist in internal audits of the quality management systems (FDA, ISO, and other regulatory audits).
Assist in the development and oversight of internal audit schedules and plans.
Identify and assist in quality system process improvements to streamline processes or 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 a complaint has previously been addressed according to relevant complaint history.
Analyze quality data and trending for presentation and discussion, including CAPA, ECO, and internal audit process metrics; assist in establishing recommended targets and goals for applicable metrics.
Identify and implement complaint process improvements to streamline processes or adjust to quality and regulatory changes.
Lead CAPAs/MIs and the CAPA process, including development of a CAPA Review Board.
Train teammates on the CAPA/MI process.
Secondary Duties
Support quality initiatives around risk analysis and risk management.
Review service records to identify potential customer complaints.
Support nonconformity report (NCMR) closure.
Support external audits in front room and back room, including serving as a backroom lead or scribe, and provide necessary training for auditing.
Education and Experience This position requires an associate degree (A.A.) from a two‑year college or university, and a minimum of two years of related experience and/or training; or an equivalent combination of education and experience. Successful completion of ISO Internal Auditor training is required.
Preferred: Familiarity with ISO 13485 and 21 CFR Part 820 requirements impacting the site they lead.
Competency / Skill Requirements
Excellent organizational skills, a high attention to detail, and the ability to multitask.
Strong writing, grammar, and proofreading abilities; able to effectively present information in one‑on‑one and small group settings and to other employees of the organization.
ISO Internal Auditor Training/Certification.
Project management experience.
Supervisory Responsibilities
N/A
Physical Demands The physical demands described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this job, the teammate is regularly required to see, talk, and hear; frequently required to sit and use hands; occasionally required to reach with hands and arms; regularly must lift and/or move up to 10 pounds; and occasionally lift and/or move up to 25 pounds.
Work Environment The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this job, the teammate is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.
Additional Information This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the teammate. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Equal Employment Opportunity Midmark Equal Employment Opportunity Employer – Minorities/Females/Disabled/Veterans
EO/AA Employer Minorities/Females/Protected Veterans/Disabled
About Us Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.
Seniority Level Entry level
Employment Type Full‑time
Job Function Quality Assurance
Industries Appliances, Electrical, and Electronics Manufacturing; Industrial Machinery Manufacturing; Medical Equipment Manufacturing
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