Overview
Quality Assurance/Quality Control Supervisor (GAS) Jobs in Stoughton, MA at Riley Brother Inc
As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.
ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.
Working as one to help many.
POSITION SUMMARY
The Quality Assurance Specialist supports the Quality Assurance function, to ensure continuous production of parts, consistent with established standards to meet customer’s specifications by performing the following duties personally, or through subordinate personnel. This position operates under minimal guidance from management or senior staff. The Quality Specialist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
To maintain and deploy the continuously improving Quality Management System; its procedures, and process controls;
Adheres to the Quality Management System and its processes to meet FDA 21 CFR 210, 21 CFR 211, & 21 CFR 820 regulatory requirements, as well as ISO 13485;
Support Internal/External Audit Programs;
Support Quality Assurance objectives to maximize product reliability, minimize costs, and enhance customer relationships;
Assist in the correct identification of root causes analysis pertaining to customer complaints/RMA’s and internal non-conformance’s, and CAPA Reports;
Identify and implement CAPA for quality issues pertaining to customer specifications, manufacturing processes, inspections/manufacturing equipment, and inspection criteria;
Identifies, proposes, and implements Quality Process and system improvements;
Assist in managing the documentation system, including documents stored at remote locations;
Coordinate management data;
Receives minimal supervision on work assignments;
Receives overall project direction from management;
Meets expectations of regular, reliable attendance;
Other duties as assigned.
QUALIFICATION, EDUCATION & EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
Bachelor’s Degree in any Life Science discipline preferred, and a minimum of three (3) years’ experience in a regulated industry (pharmaceutical/medical device);
Demonstrated PC proficiency in MS office products and MRP.
Excellent verbal and written communication skills, with the ability to coordinate customers’ expectations with production capabilities.
High sense of urgency and prioritization skills;
The ability to create positive working relationships with a diverse group of people including gender, ethnicity, age, and cultural and skill level differences;
Ability to work independently with minimal supervision;
Ability to establish priorities and meet deadlines.
Preferred:
5 years of Quality Assurance experience within a medical-related manufacturing company;
Knowledge/Training to ISO 13485:2016, Medical Devices Quality Management System.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.
Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
Exposure to buildings where a variety of chemical substances are used for cleaning, and/or operation of equipment;
The noise level in the work environment is usually minor;
Duties are performed indoors;
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS
While performing the duties of this job:
The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
Specific vision abilities required include close vision such as reading handwritten or typed material and the ability to adjust focus;
The position requires the individual to meet multiple demands from several people and interact with internal and external people;
Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
Employee may have duties involving walking on even or uneven surfaces;
Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
Employee must see and hear on a continuous basis as well as speak frequently;
Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.
ProMed offers a generous benefits package including:
401k with company match
Profit Sharing program
Medical Insurance
Health Savings Account/Flexible Spending Account
Dental Insurance
Vision Insurance
Life Insurance
Short, and Long-Term Disability Insurance
Critical Illness, Accident, and Identity Theft Protection
Pet Insurance
ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.
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Title: Quality Assurance/Quality Control Supervisor (GAS)
Company: Riley Brother Inc
Location: Stoughton, MA
