Sr. Analyst Complaints / Post Market Quality Systems - United States
Manage post market incident activities such as complaint handling, risk assessments, CAPA, MDR, market withdrawals, etc. Assist in preparing data for management review activities. Manage the post market quality system and regulatory requirements for DiaSorin Molecular, LLC to comply with all applicable regulations and standards including but not limited to FDA, ISO, as well as Federal, State, and local agencies. Supports corporate goals and business growth.
- Ensures that the quality management system demonstrates regulatory compliance per QSR, ISO, and other applicable regulations.
- Management of post-market activities including complaints, post-market incident activities, and surveillance activities quality systems.
- Collect information/data and assist in organizing them in quarterly management review reports.
- Oversight of Quality System process/es to assure compliance of FDA, ISO and various regulatory requirements.
- Trend and monitor Quality System process/es by creating reports for senior management.
- Follows corporate policies and procedures.
- Provides recommendations per the revised regulations for continuous improvements.
- Manage project logs and track quality system projects.
- May include leading project teams in creating and/or improving the Quality Systems.
- Perform quality audits as needed.
- Gather, analyze, and report data reflecting status of product
- May include leading risk assessment teams ensuring compliance to procedures and regulations.
Qualifications Experience Personal Strengths Mobility
- A minimum of five - eight years’ experience in the medical device/health industry with most of this experience working in Quality Assurance is a plus. -
- Must have experience in post market activities and complaints.
- Must have a thorough understanding of statistical analysis, Investigation and Root Cause Analysis, and Corrective and Preventive Action Process
- American Society for Quality (ASQ) certification a plus, but not required.
Thorough knowledge of Federal regulations, specifically FDA, State Regulations, ISO, and Quality Management Systems is required.
Must be proficient in Microsoft Word, Microsoft Excel and Microsoft PowerPoint.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
As per local and Company requirements for DiaSorin Molecular LLC
Others Information as per Local Legal Requirements
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future.
It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
DiaSorin is an EEO/AA employer.
EEO is the Law | http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf