You will manage the Document Control system which involves creation, approval, issuance, storage, access and distribution of all paper and electronic documents that support the Quality Management System at Paragon Medical. This position does manage a small team.

ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:

• Provide expertise in controlled document management and quality records management.
• Manage daily document control activities, coordinate /implement drawing and document revisions via the ECO and/or Pre-Production release systems.
• Management and oversight of the electronic QMS database – MedTrack including interface with system consultant for enhancements, updates and validation.
• Provide expertise and leadership to Document Control team and all associates in change control issuance, processing and approval.
• Training records management.
• Perform all Administrator duties for the MedTrack QMS database which includes creating/deleting user accounts and setting security access.
• Provide training as required for use of MedTrack.
• Provide key support to Quality Manager during all customer/regulatory audits by answering questions, taking audit notes, running reports, document retrieval, etc.
• Maintain and provide department metrics for ECO’s, training, suppliers, etc.
• Oversight of the Supplier Approval process and management of all supplier files.
• Other responsibilities as required including but not limited to Document Control Specialist’s essential duties and responsibilities

EDUCATION and/or EXPERIENCE

Required:

• 3+ years of Document Control experience
• Working knowledge of Microsoft Office applications

Desired:

• Associate or Bachelor’s degree
• Supervisory experience
• Knowledge and experience with ISO 13485:2016 and FDA QSR 21 CFR 820

SKILLS/COMPETENCIES

• Read/write/speak and understand English
• Excellent interpersonal and communication skills
• Ability to multi-task in a fast-paced environment
• Problem solving capability
• Ability to work under minimal direction and self-motivated
• Demonstrated ability to lead people, resolve conflicts and get results through others
• Ability to solve practical problems and deal with a variety of changing situations
• Knowledge of human resources and safety to include coaching, performance management, OSHA and related safety standards.

EEO Statement

Paragon Medical, a division of MW Industries, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.