Quality Associate(Document Control)

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Quality Document Control Associate

The Document Control Associate shall be responsible for maintaining Company documentation and assist in processing document change requests through eQMS software, reviewing those changes for accuracy and completeness, ensuring conformance to standard operating procedures. This position will require a strong understanding of eQMS softwares (Arena preferred) and must be comfortable with teaching it to others in the company. This position will also help to maintain training records. This position may occasionally support Regulatory Technical Documentation. Manage storage and archiving of quality system documents.

Coordinating with more other Document Control personnel, maintain the Company document control system:

• Establish and maintain procedures, policies and systems needed to meet the requirements of document control in a medical device company.
• Receive, review and process document change requests within eQMS software.
• Review change requests for accuracy, completeness and conformance to standard operating procedures.
• Support accurate compilation of Design History Files, Device Master Records and Regulatory Technical Documentation associated with Doc Control Records
• Manage storage and archiving of quality system documents
• Assist in maintaining employee training records

Qualifications

High School Diploma, Associates degree preferred. 1+ years of document control experience in a related health-care field such as in a medical device or pharmaceutical company.

Core Competencies / Skill and Abilities Required:

• Must have excellent people skill and be able to interface well with all employees.
• Must have excellent organizational skills.
• Must have experience with eQMS
• Must have excellent reading, proofreading, editing and technical writing skills and verbal communication skills in the English language.
• Must have strong computer knowledge. Proficient in Microsoft Office applications,such as Adobe Acrobat, Excel, Share Point, etc.
• Ability to work independently and resolve issues with minimal direction.
• Ability to work within deadlines to meet multiple company project goals (as applicable)
• Working knowledge of current FDA QSR and ISO 13485 documentation requirements.

Physical Demands:

• Normal Office Environment Requirements.

Job Types: Full-time, Temp-to-hire

Pay: $50,000.00 - $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• Are you ok with temp to perm?
• Can you commute to Marlborough 5 days per week?

Education:

• High school or equivalent (Preferred)

Experience:

• Quality: 1 year (Preferred)
• Document Control: 1 year (Preferred)
• eQMS: 1 year (Preferred)

Ability to Commute:

• Marlborough, MA 01752 (Required)

Ability to Relocate:

• Marlborough, MA 01752: Relocate before starting work (Required)

Work Location: In person