***This opportunity is in the Pennsylvania Area***
On-site position. The QA-QC Manager will manage the Company's Total Quality Management
System (TQM) to ensure medical products meet regulatory and technical requirements. Their duties
include managing quality personnel for developing and implementing quality control and assurance
functions. This position requires excellent verbal and written skills to keep all departments well
advised, and excellent problem-solving and leadership skills.
· Implement the TQM system, including design and implementation of policies and procedures
to ensure quality standards are being met during production
· Manage design history and risk management systems for new and existing products
· Manage change control and document control systems
· Coordinate and manage internal and external site audits
· Oversee all GMP inspections and testing of materials, parts, and products
· Monitor production and quality processes including reviewing and creating quality
documentation for equipment and processes including validations
· Manage customer complaints/returns
· Verify that the quality related site activities are in accordance with the applicable codes and
· Control all nonconformance reports and undertake Corrective and Preventive Action Plans
· Manage and oversee Technical and Safety Data Sheet documentation
· Assure all technical documents relative to site qualification is up to date
· Keep up to date with changes in national and international regulatory guidelines
· Communicate directly with GMP Production Manager regarding manufacturing issues relating
to quality standards and use critical thinking to resolve challenges
· GMP and ISO 13485 regulations.
· At least 5 years of relative quality management experience in medical device manufacturing
· Knowledge of FDA/ISO Regulated Medical Device Procedures (Preferred)
· Good communication skills and an eye for detail are required, as well as thoroughness and
ability to deal with complex issues.
· Must be a self-starter capable of managing projects from start to finish. Contribute to process
improvement, analyzing information, strategic planning, informing others, and emphasizing
· Strong computer and mathematical skills are necessary. Performs a variety of tasks. Leads
and directs the work of others. A wide degree of creativity and latitude is expected.
· Must be able to walk, sit and/or stand throughout an 8-hour day. Some operations require occasional bending, stretching, or lifting; proper lifting techniques required. Must be able to repetitively use arms, hands and fingers. Must demonstrate good hand/eye coordination and demonstrate manual dexterity. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Work environment sometimes requires special safety precautions, which may require use of personal protective equipment.
· Epicor ERP experience (Preferred)
· Bachelor's degree in relevant field.
· Day shift - 8:30 to 5:00pm/40-hour work week
· Monday to Friday
All employees who are not vaccinated are required to wear a mask when social distancing is not
possible. Vaccination is highly recommended.
For additional infromation on this opportunity, please contact Tyler Hawkins directly at 605-610-2399. Resumes may be confidentially sent to firstname.lastname@example.org
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.