POSITION TITLE / LOCATION: Quality Assurance Manager, Salisbury, MA
JOB CLASSIFICATION: Exempt
POSITION REPORTS TO: Director of Quality & Regulatory Assurance
POSITION OVERVIEWThe individual in this position will be part of a dynamic team with a proven track record of inventing, developing, and commercializing FDA registered medical devices. In this role the individual will interact with all functional areas of Ovik Health at our Mayflower Plant in Salisbury, MA. The associate will oversee the following as well as other duties as requested:
ESSENTIAL JOB DUTIES AND RESPONSIBILITIESQuality Systems- Develop, implement, communicate and maintain effectiveness of a quality system that is in compliance with FDA QSR and ISO 13485 standards
- Liaison with ISO 13485 registrar to ensure activities are completed in order to maintain ISO 13485 registration
- Manage and maintain the quality inspection and product release programs for a) incoming raw materials, b) in-process materials, c) components and d) finished goods
- Set quality assurance objectives for the review and approval of Top Management and ensure that targets are achieved
- Establish and maintain appropriate controls and documentation procedures
- Participate in new product development activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
- Support an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
- Implement new inspection, measurement and testing systems for quality monitoring and improvement
- Track and report significant quality deviations
- Develop and maintain an effective quality systems training program for all appropriate business associates
- Manage all audit activities including internal, external, supplier, and FDA audits.
- Conduct Management Reviews on a regular basis for location of responsibility
- Review and approve SPIs
- Develop, edit, review and approve validation protocols and reports.
- Provide employee development opportunities for direct reports
- Act as Management Representative for location of responsibility
- Own CAPA, NC, and Complaint programs for location of responsibility
MINIMUM QUALIFICATIONS- Strong verbal and written communications skills
- 4+ years Quality Assurance experience including 2 + years of supervisory leadership
- ISO and FDA Quality systems knowledge
- Bachelor's Degree in Science or Management preferred
- Medical Device manufacturing desirable
PREFERRED QUALIFICATIONS- Six Sigma Certification
- ISO 13485:2016
- ISO 19011:2018
PERSONAL PROTECTIVE EQUIPMENT USED:- Safety Eyewear
- Steel Toe Safety Shoes
- Hairnet
- Cut resistant gloves, chemical gloves, etc. as needed
PHYSICAL REQUIREMENTS FREQUENCY, AMOUNT, OR DESCRIPTION Standing: Ability to stand while working: 60% of day
Sitting: Ability to sit down: 40% of day
Moving: Ability to move throughout plant: 100% of day
Lifting: Ability to lift to 25 lbs.: 100% of day
Ascending/Descending: Ability to walk upstairs, climb to top of range
(approx. 16 ft): 50% of day.
Push/Pull/Reach: Ability to push/pull/reach: 5% of day
Bending: Ability to pick up objects from the floor 25% of day
Visual Acuity: Visual acuity adequate to perform job duties, including reading information from printed sources and computer screens. : 100% of day
Cognitive: Alert. Able to make decisions, reason, and understand information. : 100% of day
WORK ENVIRONMENT/SAFETY-SENSITIVE POSITIONThis job operates in a manufacturing facility. This position is a safety-sensitive position and occasionally works around moving mechanical parts and powered industrial vehicles. Noise level can be medium to loud. Temperatures can vary depending upon the time of year and outside impacts.
Pay Transparency:The salary range for this position is $91,500.00 to $135,000.00; the exact range depends on several factors such as experience, skills, education and budget.
