17 August, 2018
Join our crew! KICVentures is a private investment company founded in 2005 by Harvard-trained Dr. Kingsley R. Chin, who brings unique experience to the intersection of medicine, business and information technology. We’re equipped to identify niche healthcare opportunities and encourage total global inclusion, beginning with our team. We’re about hands-on, heads-down efforts, complemented by a company culture that fosters engagement. Collaboration drives our innovation, and we work with the best and the brightest in the business – movers and shakers who’re all hands on deck for success. As evolution happens, we revolutionize.
We’re looking for a document control specialist
You are passionate about Document Control and seeing projects to completion with a diverse workload. Professionally, you are someone who rolls up their sleeves and dives into projects with vigor. You enjoy change and influencing change for process and document improvement. You want to be part of a growing Quality team that’s driven by the desire to positively influence other team members and see our products be the best they can be.
The organization you want to work for should be innovative and exciting, challenging the status quo, always adapting and encouraging employees to take initiative. Perhaps you even have a special interest in the healthcare technology and wellness industries.
You will report to the Quality Manager. You will thrive at AxioMed by being proactive, solution-oriented, organized and have superb attention to detail with a dedication to thoroughness.
Develop and maintain record retention and archive process. Bring record and document control area into compliance. Identify improvement opportunities. Support quality, product development, and manufacturing department record control function. Be able to quickly learn companies EDM system to import records, perform document control reviews, and maintain QMS documentation. Must be able to review records for completion, obtain any information make necessary changes using GDPs. Handle filing of paper records, including copying, scanning, and securing signatures.
Duties and responsibilities
- Organize and maintain hard copy, electronic, and EDMs controlled records and documents including DHF, 510K, LHRs, etc.
- Maintenance of historical records (manual and electronic): archiving of hard copy records, managing of outside archival resources, and manage Document Control Room
- Maintain chain of custody on requested records
- Perform document control QC check of QMS documents
- Maintain backups of logs and records
- Manage change control activities
- Supervise temps for special short-term document control projects
- Provide assistance for document research projects
- Assist with assembling documentation packages for regulatory agencies
- Audit support
- Administrative assistance to VP QA/RA
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.
- High School Diploma
- 3-4 year of experience in Document Control, preferably in an ISO 13485 or FDA regulated environment.
- Knowledge of ISO 13485, FDA and MDD concepts and guidelines preferred.
- Must be able to work within a EDM system
- Understand and implement GDPs
- Excellent communication and organizational skills.
- Strong attention to detail.
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner in office environment.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Knowledge of various MS Office applications such as: Word, Excel, Powerpoint and Visio.
- Ability to handle multiple tasks in a fast paced environment and still provide accurate and complete work.
Work is generally performed within an office environment, with standard office equipment available. Travel between Malden and Woburn location as necessary.
- This position operates in a mainly clerical setting. Routinely uses standard equipment, telephones, photocopiers, filing cabinets etc.
- Sitting for extended periods of time using a computer keyboard and monitor
- Routinely needs to do filing, which will require opening file cabinet drawers, being able to bend for file placement.
- The position frequently requires files to be moved from one place to another under 20 pounds lifting is periodically needed.
- Worker is required to have the visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
- Worker is required to have close visual acuity to perform and analyzing data and figures, viewing a computer terminal; extensive reading at a distance that is close to the eyes.
- Must be able to read, write and communicate fluently in English
Greater Boston area
Interested candidates, please send resume and cover letter to email@example.com
Please no outside unsolicited recruiters