What are the responsibilities and job description for the Validation Specialist position at PTS Diagnostics?
Summary
Job Description
The Validation Specialist is responsible for ensuring that PTS medical devices, manufacturing processes, equipment, and systems, comply with industry standards and regulations.
Essential Duties And Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and meet or exceed the experience requirements listed below.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employees work in a typical office environment.
EQUAL OPPORTUNITY EMPLOYER PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.
STATEMENT Of OTHER DUTIES DISCLAIMER
This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.
Company Description
PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
Job Description
The Validation Specialist is responsible for ensuring that PTS medical devices, manufacturing processes, equipment, and systems, comply with industry standards and regulations.
Essential Duties And Responsibilities
- Developing and executing verification and validation protocols, conducting tests, analyzing data, documenting results, and generating detailed reports to verify product quality and compliance for the following areas:
- Medical devices and chemistry strips used in whole blood analysis
- Equipment qualification (IQ, OQ, PQ)
- Software that is or is part of a medical device
- Software that supports the Quality System
- Process validation
- Test Method Validation
- Ensuring requirements (user, product, process, etc.) are clear, unambiguous, and testable.
- Reviewing supplier process and part verification documentation.
- Generating verification and validation report summaries and logging issues.
- Collaborating with cross-functional teams to identify and resolve issues throughout the validation process.
- Assisting in product and process risk analyses (FMEA, PFMEA, Hazard Analysis, etc.).
- Supporting continuous improvement through nonconformity investigations and corrective and preventive actions (CAPA).
- Review and approval of engineering change requests.
- Utilize issue tracking software.
- Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and meet or exceed the experience requirements listed below.
- Proficient in the use of software development tools (compilers, emulators, and chip programmers).
- Working knowledge of software design verification and validation activities in the medical device industry (US and OUS).
- Ability to comprehend specifications including drawings, data sheets, and schematics.
- Bachelor’s degree, or associate’s degree plus 5 years’ experience, in science or engineering field
- 3 years’ experience in and knowledge of validation requirements (IQ, OQ, PQ, process validation, software validation, revalidation, etc.)
- Experience with clinical studies desired
- Medical device industry preferred (familiar with 21 CFR 820, ISO 13485, IVDR, etc.)
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Employees work in a typical office environment.
EQUAL OPPORTUNITY EMPLOYER PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.
STATEMENT Of OTHER DUTIES DISCLAIMER
This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.
Company Description
PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
