Quality Assurance Manager - Med Devices job Easton Pennsylvania
Quality Assurance Manager - Med Devices job Easton Pennsylvania
My Spider Scam Awareness Contacting Us F. A. Q.
 
Job Seekers
Search Jobs
Browse Jobs
Post a Resume
Job Alerts
 
Employers
Search Resumes
Browse Resumes
Post a Job

Quality Assurance Manager - Med Devices Job



Employer Name: SpiderID: 12534307
Location: Easton, Pennsylvania Date Posted: 5/16/2022
Wage: $75000 - $100000 per year Category: Healthcare
Job Code: TBH QA Mgr

Job Description:

***This opportunity is in the Pennsylvania Area***



Job Summary:


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.



Responsibilities:


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


standards


Control all nonconformance reports and undertake Corrective and Preventive Action Plans


(CAPAs)


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



Experience:


GMP and ISO 13485 regulations.


At least 5 years of relative quality management experience in medical device manufacturing


operation


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


excellence.


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)



Education:


Bachelor's degree in relevant field.



Schedule:


Day shift - 8:30 to 5:00pm/40-hour work week


Monday to Friday



COVID-19 considerations:


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 tyler.hawkins@gogpac.com




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.



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: GPAC Company Type:
Company: GPAC
City:
State:
Zip:

Send ad to a friend


    





© 2022 Job Spider
Privacy Policy | CC Marketing Sites | Site Map | Links