Quality Specialist II - Batch Release

About Us:

Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities. Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market.

For additional information, visit our website at www.Poly-Med.com.

Our Team:

We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.

Employee Benefits and Information:

• Health, Dental and vision coverage options
• Life, short and long term disability insurances
• 401(k) plan with employer matching
• Pay period is once a month.

Description for Quality Specialist:

This position is self-directed and is responsible for performing quality assurance tasks and activities with minimal guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within Quality Assurance field. Relies on personal experience and judgment to perform primary job responsibilities.

Responsibilities for Quality Specialist:

Quality Specialist II is a level of skill and experience that may be tasked with any or all of the following responsibilities but may be assigned to predominantly perform specific functions.

• Performs document management and maintenance, including lab notebook management, document binders, and document archival duties in its various forms.
• Responsible for ECO system management.
• Responsible for reviewing, managing, and maintaining documents, including MIs, MIFs, DHR, DMR, DMF, Label Control, and Shipment paperwork.
• Responsible for checking the prepared shipments; labeling, packaging, and associated shipment documentation.
• Performs basic clerical duties as required to ensure compliance to ISO 13485 and 21 CFR part 820.
• Seeks resolution to issues encountered during routine quality duties.
• Supports multiple aspects of compliance for the Quality System as needed.
• Coordinates and plans required documentation for product realization and shipments.
• Makes suggestions for improvements to current documentation processes and systems.
• Provides critical reviews of all PMI documentation as required.
• Participates in internal auditing.
• Participates in external audits as required.
• Performs other duties as assigned.

Required/Preferable Knowledge, Skills and Abilities for Quality Specialist: Proficiency in Microsoft Office Software (Microsoft Word, Excel, et. al.) Excellent organizational skills

• Ability to assertively interact with people at all levels of the organization
• Good technical writing skills, grammar
• Ability to manage time and prioritize, as well as multi-task
• Ability to handle highly confidential business information
• Strong attention to detail
• Ability to think proactively

Minimum Requirements

• Education: High School diploma or GED, plus document control experience in a FDA regulated environment. Preferred Associates or Bachelors degree.
• Years of Experience: 3-5 years

Working Conditions at Poly-Med, Inc.:

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Job Type: Full-time

Pay: $42,000.00 - $59,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Education:

• High school or equivalent (Preferred)

Experience:

• ISO 13485: 1 year (Required)
• Microsoft Office: 1 year (Required)
• Document review: 3 years (Required)
• Document management: 3 years (Required)
• FDA regulations: 1 year (Required)
• batch release: 2 years (Required)

Work Location: In person

Salary : $42,000 - $59,000