Job Summary: The Quality Supervisor (QS) will call upon their experiences working in highly regulated industries and strong working knowledge with ISO 13485 or ISO 9001 and cGMP to ensure all quality initiatives and requirements are achieved to the highest degree.
The QS drives company strategic goals by working closely with operations personnel to problem solve and facilitate continuous improvement efforts.
As the quality management representative, the QS will maintain the Quality Management System.
Responsibilities:
Ensures production batch records are thoroughly completed, reviewed and approved in a timely manner.
Maintains and updates the Quality Management System.
Trains new and existing personnel on ISO based quality management system.
Participate in the coordination and execution of Operations Quality Management System.
Works to insure process and procedures are controlled, accurate in reflecting the current process and meets expectations as defined by ISO policy.
Provides leadership for Quality Management System audits, internal, external, customer and supplier audits.
Will be responsible for assisting in coordinating corrective/preventive actions, continual improvement, customer complaints and non-conformances and investigating root cause and effectiveness of actions taken.
Working with Product Development/Management, associates, contractors, and outsourcing firms to develop product requirements.
Assist in conducting quarterly management meetings and prepare reports.
Implements and manages Supplier Quality Program including but not limited to setting up material specification sheets, on-site supplier audits, desktop supplier audits, Receiving Inspection Process, issuing and resolving CAPAs.
Ensures that Validation program is in compliance with company policies.
Conduct FMEAs (PFMEA, DFMEA, SFMEA, etc.
)
Provides effective Quality representation on Research and Product Development teams.
Ensure Product/Design History Files are adequately maintained.
Ensures products are developed in compliance to applicable regulations and standards.
Investigates customer complaints and internal CAPAs by utilizing formal root cause analysis methods.
Manages CAPA system and Quarantine processes.
Conducts internal audits as needed.
Analyzes relevant manufacturing data and creating trending analysis for senior management based on quality documentation.
Other responsibilities as assigned
To be considered you?ll need:
A bachelor?s degree or an associate degree +2 additional years of experience.
A minimum of 3 years of relevant work experience in a GMP environment.
Keen attention to detail.
Solid company-centric ideology.
Creative problem-solving skills.
The ability to balance multiple priorities.
Core values of honesty and respect.
A thirst for learning.
The desire to be challenged.
You?ll be a great if you:
Thrive in an autonomous work environment.
Have a LEAN mindset.
Are the first person to help.
Seek out opportunities to bring added value.
Company Benefits & Perks
401K
Health Benefits: Medical, Dental, Vision
Wellness Program
Life Insurance
Corporate Sponsored Events
Skill growth opportunities
Short Term Disability
Ability to Advance
Working with energetic & creative problem solvers
A mission worthy of your energy and expertise
Applicants for this position must successfully pass a background and drug screening.
It is impossible to list every requirement for, or responsibility of, any position.
Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time.
Therefore, the above job description is not comprehensive or exhaustive.
The Company reserves the right to adjust, add to or eliminate any aspect of the above description.
The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
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