What are the responsibilities and job description for the Quality Associate/Specialist position at Confidential?
Small business medical device manufacturer in downtown Dover looking for a QA Specialist to support the Quality Manager and Inspection personnel.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Assist the Quality Manager with Quality and Regulatory functions for Devices, Accessories, OEM Products, and Repairs. Quality and Regulatory Functions include, but are not limited to:
- Document and Change Control
- Post-Market Surveillance Activities
- Support Various Audits (FDA, Notified/Regulatory Bodies, Internal Audits)
- Risk Management Activities
- Product and Facility Registration
- Assist the Quality Manager with scheduling and overseeing the inventory levels on finished devices, accessories, and consumables
- Interface with customers and suppliers regarding quality, delivery, cost of materials, specifications, and other requirements where and when applicable.
- Assist the Quality Manager with creating, implementing, and the distribution of reports to required personnel regarding status of various functions and projects
- Assist the Quality Manager with creating, implementing, and the distribution of reports required by applicable regulatory authorities and notified bodies
- Approve and Sign documentation with the same authority as the Quality Manager
- Assist with projects as required
- Must be able to read, write, and comprehend instructions.
- Must be able to lift, bend, sit and have manual dexterity.
Desired Minimum Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- A bachelor’s or Associates degree in science or engineering.
- A minimum of 3 years’ experience in the FDA regulated industry of Medical Devices working as a Quality Assurance/Quality Control professional.
· Or experience working in another regulated industry that adheres to ISO Quality Standards
- Familiarity with FDA Quality Management System Regulations, ISO Quality Standards, principles of quality control inspecting/testing of medical devices.
· Or familiarity working in another regulated industry that adheres to ISO Quality Standards
- Proven experience working with suppliers and customers of Medical Devices.
- Skills in conducting quality system audits (internal and external) and managing corrective actions to completion.
- Problem solving skills including performing root cause investigations and preparing written reports of findings.
- Skills at tracking, trending, and reporting key quality metrics.
- Ability to communicate successfully with co-workers, customers, and suppliers
- Must be able to read, write, and comprehend instructions.
- Must be able to lift, bend, sit and use manual dexterity.
Hours: 9am to 5pm Monday through Friday.
Work Location: In person in an old mill building.
Pay: $60,000.00 - $70,000.00 per year
Benefits:
- AD&D insurance
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Do you live within a 1 hr commute of Dover, NH?
Language:
- English (Required)
Work Location: In person
Salary : $60,000 - $70,000