What are the responsibilities and job description for the Product Support Specialist position at PTS Diagnostics?
SUMMARY
This position performs laboratory experiments and generates reports related to those activities related to product performance surveillance and complaint investigations. This position is attentive throughout the complaint investigation process to ensure complaints are fully investigated and their findings are conveyed to the appropriate components of the quality system, while ensuring quality is upheld during the complaint investigation process and customer safety is the number one concern.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Process and perform analysis of PTS test strips using whole blood and control materials.
Conducts investigations and/or experiments to test system performance which may include chemistry, architecture, and/or analyzer issues relating to all complaints.
Conveys complaint investigation findings to the Product Support Scientist and elevates findings to the Quality Control Manager and/or Head of Quality, if warranted.
Ensures complaints are fully investigated, conducts further action as required and close items within a specific time frame.
Assists in the management of the complaint resolution process.
Captures and records test data utilizing PTS procedures.
Prepares blood samples for analysis following established protocols.
Assists with quality and research studies as required.
Performs testing using reference analyzers and/or OEM systems.
Data entry and analysis
Enter data collected into Microsoft Excel file, analyzes and prepares formal reports.
Generates reports and/or charts using Microsoft Excel and/or Microsoft Word.
QUALIFICATIONS
Detail oriented
Possess strong verbal and written communication skills
Able to interpret and follow written and verbal instructions
Knowledge of good laboratory practice in a regulated industry is required
Working knowledge of applicable FDA and ISO regulations
Working knowledge of Quality System Regulations
Adept at interfacing with various disciplines in an organization
Familiar with statistical techniques
EDUCATION and/or EXPERIENCE
Bachelors’ degree (B.S.) in Chemistry, Biology, Medical Technology or related field from an accredited four-year college or university is preferred.
Five (5) years related experience and/or training in the Medical device or related industry.
Or, equivalent combination of education and experience
WORK ENVIRONMENT
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.
Individual works in a typical laboratory environment. Lab coat, safety glasses, and gloves are required when performing test procedures.
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.
QUALITY COMMITMENT
This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.
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. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.
This position performs laboratory experiments and generates reports related to those activities related to product performance surveillance and complaint investigations. This position is attentive throughout the complaint investigation process to ensure complaints are fully investigated and their findings are conveyed to the appropriate components of the quality system, while ensuring quality is upheld during the complaint investigation process and customer safety is the number one concern.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Process and perform analysis of PTS test strips using whole blood and control materials.
Conducts investigations and/or experiments to test system performance which may include chemistry, architecture, and/or analyzer issues relating to all complaints.
Conveys complaint investigation findings to the Product Support Scientist and elevates findings to the Quality Control Manager and/or Head of Quality, if warranted.
Ensures complaints are fully investigated, conducts further action as required and close items within a specific time frame.
Assists in the management of the complaint resolution process.
Captures and records test data utilizing PTS procedures.
Prepares blood samples for analysis following established protocols.
Assists with quality and research studies as required.
Performs testing using reference analyzers and/or OEM systems.
Data entry and analysis
Enter data collected into Microsoft Excel file, analyzes and prepares formal reports.
Generates reports and/or charts using Microsoft Excel and/or Microsoft Word.
QUALIFICATIONS
Detail oriented
Possess strong verbal and written communication skills
Able to interpret and follow written and verbal instructions
Knowledge of good laboratory practice in a regulated industry is required
Working knowledge of applicable FDA and ISO regulations
Working knowledge of Quality System Regulations
Adept at interfacing with various disciplines in an organization
Familiar with statistical techniques
EDUCATION and/or EXPERIENCE
Bachelors’ degree (B.S.) in Chemistry, Biology, Medical Technology or related field from an accredited four-year college or university is preferred.
Five (5) years related experience and/or training in the Medical device or related industry.
Or, equivalent combination of education and experience
WORK ENVIRONMENT
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.
Individual works in a typical laboratory environment. Lab coat, safety glasses, and gloves are required when performing test procedures.
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.
QUALITY COMMITMENT
This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.
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. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.
