MAIN JOB RESPONSIBILITIES / COMPETENCIES
1. Act as consolidation point for receiving, processing, investigating and reporting product complaints.
2. Coordinate and/or perform the evaluation, investigation, follow-up and documentation of all STAAR product complaints. Maintain complaint files.
3. Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to:
Interface with physicians and/or health care professionals regarding information relevant to the product complaint.Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements.
4. Perform prompt handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse events according to procedures.
5. Inform management responsible for complaint handling when information in a complaint suggests that action may be required to prevent unreasonable risk of substantial harm to the public, that there is an indication of a trend or that there are unusual adverse events.
6. Ensure incident reports (e.g. Medical Device Reports, Health Canada Reports, Vigilance reports, etc.) are submitted in compliance with respective regulations (e.g. U.S. FDA Regulations, Canadian Medical Device Regulations, MDD/MDR, MDSAP, etc.)
7. Ensure accuracy, integrity, completeness and consistent content of product complaint reports, investigations, incident reports, in the complaint files and electronic complaint database.
8. Support external (e.g. FDA, DEKRA, etc.) and internal audits as required.
9. Provide support, as required for other aspects of the post-market surveillance system (i.e., data analysis of complaint reports, files and adverse event reporting logs).
10. Provide support for medical affairs activities, as requested.
11. Other duties as assigned.REQUIREMENTS EDUCATION & TRAINING
• High School graduate or equivalent required. Associate's Degree or higher desired.
EXPERIENCE
• 1 year's ophthalmic experience, or equivalent combination of education and experience, preferred.
• 3 years' experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable.
• Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, including but not limited to, CFRs, ISO 13485, MDD, CMDR, MDSAP, MDR.
SKILLS
• Proficiency in MS Word and Excel.
• Ability to work well within a team and interdepartmentally.
• Special competencies: timely and quality decision making; well-developed organizational ability, time management reasoning and problem-solving skills.
• Good communication skills, written and verbal.
Pay range: $25 - $32 per hour - Final compensation/salary will depend on experience.
STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.
#J-18808-Ljbffr