Company Name: Apex Resource Technologies
Location: Massachusetts
Responsible for the management and maintenance of the documentation system.
Duties and Responsibilities:
- Manage the operation of the IQMS documentation control system in a timely fashion to ensure the latest revisions of documents are available and accurate records are kept at all stages of the process.
- Participate in contract review to ensure job packets are designed to meet internal and customer requirement.
- Perform Certificate of Compliance to ensure products are manufactured in compliance with regulatory and customer requirements.
- Assist Document QA engineer with validation documentation activities ( preparing technical protocols and reports)
- Act as a leader for process improvement projects regarding documentation.
- Perform other duties as needed such as audits , inspections , data analysis to ensure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control method
- Other duties as assigned
Skills/Qualifications:
- Associate Degree or equivalent, or 2-3 years’ related experience and/or training , or equivalent combination of education and experience in documentation control in the medical industry
- Strong Computer skills; Microsoft Office ( Word, Excel) and Minitab
- Must have a strong attention to details
- Leadership skills and team player
- Highly organized
- Ability to work with a high volume of documents in a fast paced environment
- Strong written , verbal , time management and interpersonal skills
Physical Requirements:
- Must be able to lift up to 25 lbs.
- Must be able to sit or stand for long periods of time
- Must be able to climb up and down stairs
Other Special Requirements:
- Support cross functional teams and departments as required
- Perform job duties in accordance to ISO 13485/9001 including ISO audits
- Travel is required to support company initiatives
To apply, if interested, please submit a cover letter and formal resume to job060915@gmail.com