6 Document Control Coordinator Jobs in Romulus, MI
Kerr Dental is Hiring a Document Control Coordinator Near Romulus, MI
Essential Duties And Responsibilities
- Other duties may be assigned, in addition to those identified below.
- Performs all duties in compliance with FDA, ISO, EPA, OSHA, and other current regulatory requirements.
- Maintain original and authorized copies of quality system documents, or other components of the quality system. Maintain all records in an accurate and orderly condition and readily available for review or audit by authorized personnel. These records include: Device Master Records, product and component specifications, Electronic Change Orders (ECOs) and any other files or records which QA management may designate.
- Maintains Device Master Records by processing Engineering Change Orders as submitted to Document Control for implementation into the quality system. This includes completion of all required supporting actions/documentation prior to final issue.
- Assist in the facilitation of any audits performed by corporate auditors or external inspectors/assessors. May assist with internal auditing of the quality system.
- Perform various other tasks and administrative assistance as may be required by QA management in support of the quality assurance system.
- Assist with other quality system processes such as Corrective & Preventive Action (CAPA), Material Review Board (MRB), Complaint Handling, Post Market Surveillance, etc.
- May be required to provide similar assistance to other Document Control departments within the corporation as directed by QA management.
- Associate’s degree or equivalent experience in Medical Device Quality Systems and Document Control
- A minimum of 2 years’ experience in quality assurance or quality systems required; medical device or dental industry experience is preferred
- Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Excel, Word and PowerPoint) required. Familiarity with electronic document control software preferred.
- Ability to organize and maintain accurate, legible, quality system records and associated and supporting documentation.
- Experience with Master Control and/or Oracle is a plus
- Working knowledge of the FDA Drug Regulations, FDA medical device Quality Systems Regulations and international quality system standards is preferred
- Must be able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, and working individually and with others within and outside his/her function.
- Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
- Must show self-initiative but be comfortable in the role of a team player. Must be able to manage multiple projects and report progress against goals in an objective manner.
- Proficiency in project leadership and management.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Analytical Decision-Making
- Communication
- Learning & Development
- Planning & Organizing
- Professionalism & Integrity
- Risk-Taking/Creative Thinking
- Teamwork & Relationship-Building
Operating CompanyKerr
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
Job Summary
Full Time
$54k-73k (estimate)
06/03/2024
07/25/2024
The job skills required for Document Control Coordinator include Leadership, Planning, Microsoft Office, Initiative, Quality Assurance, Problem Solving, etc. Having related job skills and expertise will give you an advantage when applying to be a Document Control Coordinator. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Document Control Coordinator. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Document Control Coordinator positions, which can be used as a reference in future career path planning. As a Document Control Coordinator, it can be promoted into senior positions as a Document Control Assistant III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Document Control Coordinator. You can explore the career advancement for a Document Control Coordinator below and select your interested title to get hiring information.
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