What are the responsibilities and job description for the Quality Assurance Specialist (Post-Market) position at Hologic Careers?
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most products produced are utilized onboard innovative and fully automated sample-to-result instrument systems. The consumables required for patient testing are integral to our business. The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.
Our Quality Assurance department is looking for a dedicated Quality Specialist to join our Post-Market Quality Assurance team. The ideal candidate will be responsible for monitoring and facilitating post-market complaints, ensuring compliance with applicable industry regulations, standards and company policy.
Essential Duties and Responsibilities
- Review and process complaint records in a timely manner, per Standard Operating Procedure (SOP) requirements
- Identify and escalate higher-level issues, including but not limited to Complaint Trends, Potential Adverse Events and Non-Conformances
- Process corrective/preventive action records to support complaints, audit observations, and process improvements.
- Work on problems of minor to moderate scope.
- Identify and escalate issues for further investigation, as appropriate.
- Perform queries to provide complaint and ad hoc trend analysis on reported product problems.
- Complete trainings in a timely manner.
- Ensure data is accurate, timely, relevant, and complete.
- Build productive working relationships with Team members and collaborate with cross-functional teams to resolve Quality issues in a timely manner.
- Assist in preparation for internal audits and external inspections.
- Assists in development, maintenance, and reporting of department metrics
- Assists with Adverse Event Reporting
- Assist in developing/updating department procedures and other controlled documents.
- Assists with various projects and duties as assigned
- Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Qualifications
- Bachelor’s Degree, preferably in a Healthcare/Science related field.
- 2 - 4 years of prior experience in Medical Device Post-Market Quality Assurance is preferred.
- Certification in Quality Management System and/or knowledge of Hologic Diagnostic Assays and Instruments is a plus.
- Team player with strong interpersonal and organizational skills.
- Detail-oriented, strong analytical and problem-solving skills
- Excellent written, verbal and presentation skills.
- Computer literate - able to use Microsoft Office programs, business systems and spreadsheet programs
The annualized base salary range for this role is $69,000 to $85,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
We offer a competitive salary and annual bonus scheme, and one of our Talent Partners would be happy to discuss this in more detail with you.
If you have the right skills and experience, apply today!
#LI-RF1 #Mid-level
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.
