Epimed is a development, design, manufacturing, and distribution company creating innovative medical products for over 45 years. Our focus is to provide effective high quality specialty devices mainly made by us in the areas of pain management and regional anesthesia. Epimed has been a safety/outcome/ clinically focus company since the beginning based on our high-level relationship with our customers. We strive to continually make and develop a variety of innovative, patented solutions for physicians with an emphasis on safety, outcomes and costs. Epimed has facilities located in Upstate New York and the Dallas/Fort Worth area. We have direct sales representatives across the US including Europe and distribute in over 45 countries. Several of our products have been developed with our customers to solve problems, reduce complications and provide better care of their and others patients.

The Quality Assurance Analyst is expected to provide assistance to the Manager of QA for the development, implementation, and coordination of Epimed's Quality System as directed by performing necessary duties personally or through collaboration with other personnel.

Essential Duties and Responsibilities: (others may be assigned)

• Provide quality support to any department that will require assistance.
• Contributes to writing Corrective Action/Preventive Action reports.
• Contributes to the writing of quality assurance policies and procedures, where applicable.
• Act as focal point for Epimed’s complaint handling procedures and responsibilities.
• Act as Recall Coordinator in instances where a recall must be conducted.
• Assists Regulatory Affairs Specialist in preparation of Epimed’s Post Market Surveillance Reports.
• Report incidents to the FDA, or perform Vigilance Reporting when required.
• Assists in the completion of Corrective and Preventive Actions per Epimed Quality System procedures as initiator or through team involvement. Manages the proper filing of completed Corrective and Preventative Actions in Quality Records.
• Is trained as a Lead Auditor and performs internal audits and supplier audits per Epimed Quality System procedures.
• Creates and revises technical drawings (IHR, RT, TLF) for Quality Assurance purposes, in collaboration with document control.
• Equipment Maintenance Verification
• Front office training
• Contributes to writing and revising Quality Assurance policies and procedures.
• Assists in writing and executing MRB’s and product Rework where necessary.

Qualifications:

The requirements listed above are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

Education and/or Experience:

Bachelor’s Degree (B.A.) or equivalent from four-year college or university; or three or more years related medical device/quality system experience and training; or equivalent combination of education and experience.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from management, clients, vendors, and regulatory bodies.

Mathematical Skills:

Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.

Reasonable Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions, to define problems, collect data, establish facts, and draw valid conclusions.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions, to define problems, collect data, establish facts, and draw valid conclusions.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel; reach with arms; and talk or hear. The employee frequently is required to walk and sit. The employee is occasionally required to stand and stoop, kneel or crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations bay be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles and risk of electric shock. The noise level in the work environment is usually moderate.

Ability to work alone and under supervision.

** This is non-remote position **

Job Type: Full-time

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

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Quality control: 1 year (Required)
• with medical products: 1 year (Required)
• Technical writing: 1 year (Required)

Ability to Relocate:

• Johnstown, NY 12095: Relocate before starting work (Required)

Work Location: In person