Quality Assurance Specialist 2
San Diego, CA San Diego, CA $62,100 - $97,000 a year $62,100 - $97,000 a year 1 day ago 1 day ago 1 day ago So why join Hologic? Hologic, Inc.
is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products.
The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health.
With a unified suite of technologies and a robust research and development program, Hologic is dedicated to the Science of Sure.
There has never been a more exciting time to join us.
Bright people, working together to pioneer advances in human health care, have created Hologic's success.
Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
Our work atmosphere is stimulating, innovative and customer focused.
We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are rapidly growing and yet we have never been more focused - on our people, on our growth, on our future.
Job Position Key Accountabilities / Responsibilities Screening complaints record and processing the records per Standard Operating Procedure (SOP) requirements Assess incoming Product Quality Complaints of more complicated nature, such as assay complaints, in a timely manner as per procedure.
Escalate potential issues/ incidents to supervisor or higher-level Quality Specialists, including but not limited to Field alerts, MDRs or possible recall situations.
Processes higher level corrective/preventive action records to support complaints, audit observations and process improvements.
Works on problems of moderate to major scope, such as assay complaints Escalates issues to investigation owner for further processing, as deemed necessary.
Reviews investigations and provides feedback Determines product complaint root cause codes based on the issue and severity of the complaint.
Performs queries to provide complaint and ad hoc trend analysis on reported product problems.
Facilitates CAPAs as necessary Proposes, plans and executes MyCIs.
Interacts/coordinates with and supports other departments and build productive working relationships with internal stakeholders.
Ensures no past due records Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
Review and assess the appropriateness of document changes in accordance with internal procedure.
May develop, analyze, trend, maintain, and report department metrics and complaint trending.
Ensures training is completed in a timely manner.
Assist in training new employees.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects and duties as assigned The total compensation range for this role is $62,100 to $97,000 and it is bonus eligible.
Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department.
In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.
All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc.
is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-AH1.
Estimated Salary: $20 to $28 per hour based on qualifications.
is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products.
The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health.
With a unified suite of technologies and a robust research and development program, Hologic is dedicated to the Science of Sure.
There has never been a more exciting time to join us.
Bright people, working together to pioneer advances in human health care, have created Hologic's success.
Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
Our work atmosphere is stimulating, innovative and customer focused.
We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are rapidly growing and yet we have never been more focused - on our people, on our growth, on our future.
Job Position Key Accountabilities / Responsibilities Screening complaints record and processing the records per Standard Operating Procedure (SOP) requirements Assess incoming Product Quality Complaints of more complicated nature, such as assay complaints, in a timely manner as per procedure.
Escalate potential issues/ incidents to supervisor or higher-level Quality Specialists, including but not limited to Field alerts, MDRs or possible recall situations.
Processes higher level corrective/preventive action records to support complaints, audit observations and process improvements.
Works on problems of moderate to major scope, such as assay complaints Escalates issues to investigation owner for further processing, as deemed necessary.
Reviews investigations and provides feedback Determines product complaint root cause codes based on the issue and severity of the complaint.
Performs queries to provide complaint and ad hoc trend analysis on reported product problems.
Facilitates CAPAs as necessary Proposes, plans and executes MyCIs.
Interacts/coordinates with and supports other departments and build productive working relationships with internal stakeholders.
Ensures no past due records Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
Review and assess the appropriateness of document changes in accordance with internal procedure.
May develop, analyze, trend, maintain, and report department metrics and complaint trending.
Ensures training is completed in a timely manner.
Assist in training new employees.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects and duties as assigned The total compensation range for this role is $62,100 to $97,000 and it is bonus eligible.
Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department.
In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.
All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc.
is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-AH1.
Estimated Salary: $20 to $28 per hour based on qualifications.
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