Job DescriptionJOB SUMMARY: Administers and maintains Midmark Corporations' regulated document control processes, manual and electronic, in accordance with FDA and ISO regulation by performing the following duties. ESSENTIAL/PRIMARY DUTIES:
- Reviews quality system documents to assure they align with company procedures and work Instructions.
- Assists specialist II or quality process supervisor in preparing information for change control board (CCB).
- Works in the engineering change orders (ECO) process, ensuring good document control practices are followed.
- Acts as a core member of ECO workflow team as the document control reviewer and approver.
- Follows the quality record management procedure, work instruction and forms for processes.
- Helps identify document control process improvements to streamline processes in document control or to adjust to changes in quality and regulatory requirements.
SECONDARY DUTIES:
- May support external audits in front room, back room or as scribe.
- May support internal audit as an approved auditor.
- Performs quality department project work as needed.
EDUCATION and/or EXPERIENCE: Two years' related experience and or training; or equivalent combination of education and experience. Familiarity with ISO 13485 and 21 CFR Part 820 requirements as they pertain to this position, preferred. COMPETENCY and/or SKILL:
- Excellent organizational skills, 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
SUPERVISORY RESPONSIBILITIES:
- No supervisory responsibilities
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. EO/AA Employer Minorities/Females/Protected Veterans/Disabled