Quality Assurance Manager - Med Devices job Easton Pennsylvania
Quality Assurance Manager - Med Devices job Easton Pennsylvania
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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.


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

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

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