Element Materials Technology Quality Assurance Manager in Ann Arbor, Michigan
Avomeen, proud to be part of Element is hiring for a Quality Assurance Manager . The QA Manager is responsible for developing, coordinating, maintaining and supervising the implementation and maintenance of a GMP compliant Quality Management System throughout the laboratory as Management Representative.
Manager of the Quality Assurance (QA) unit. Responsible for developing, coordinating, implementing and monitoring a quality management system throughout the facility that is compliant with regulatory requirements set forth by the DEA, FDA, and ISO 17025
Performs internal and periodic audits of the laboratory, manufacturing operations, work processes and quality records to ensure compliance with regulatory requirements, standard operating procedures, and polices
Manages the controlled substance (CS) program and ensures compliance with DEA requirements. Assists in procuring, storing, inventorying, and disposal of CS
Manages accreditation applications and renewals including DEA licensing, FDA registration, and ISO 17025. In addition, coordinates and responds to regulatory, client, and 3rd party quality assessments
Manages the document control system including development, review, and revision of SOPs and policies, document archival, and record retention
Trends, monitors, and improves the major areas of the quality system such as CAPA, change control, customer feedback and complaints, investigations, deviations, and on time delivery
Developments and implements on-going employee training programs related to the quality management system
Manages metrology and preventative maintenance program to ensure instruments and equipment are in good working order and properly qualified and calibrated per their pre-determined frequencies
Performs other related duties as assigned
Skills / Qualifications
Bachelor’s Degree Required
5-10 years’ experience in QA
Excellent problem-solving abilities and an attitude of learning
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Ability to function well in a high-paced and at times stressful environment
We are Element, one of the fastest growing testing, inspection, certification and calibration business in the world.
We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.
Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.
Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.
We have four values that we strive to live by every single day.
• Safety - We keep our colleagues and visitors safe.
• Integrity - We act honestly and fairly to do the right thing.
• Excellence - We set new standards of excellence in everything we do.
• Partnership - We work together for the benefit of our customers.
When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY. We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.
TIC Council Statement
Element is proud to be a full member of the Testing, Inspection & Certification Council (the “TIC Council”), an international association representing independent testing, inspection and certification companies.
Members of the TIC Council must implement and abide by the TIC Council Compliance Code. Element has therefore issued an overarching Code of Conduct which is supported by our Compliance Programme. A copy of the Code of Conduct and more information about our Compliance Programme can be found in theGovernance and Integrity (https://www.element.com/about-element/governance-and-integrity) section of www.element.com .
Job Locations US-MI-Ann Arbor