What are the responsibilities and job description for the Quality Assurance Specialist position at PMCO?
PMCO is hiring a Quality Assurance Specialist in Earth City, MO.
Salary: $56,000 yearly
Shift: Monday – Friday 7:00am – 3:30pm
Location: Earth City, MO
Position Summary:
Administer the complaint handling unit functions in compliance with all applicable laws/regulations. Liaise with technicians to record complaint investigations and close out cases in a timely manner. Assist in carrying out tasks for changes in the Quality Management System (QMS) and coordinate the implementation of new or revised quality processes, procedures, work instructions, and standards as applicable.
Job Duties and Responsibilities
- Process customer complaints, service, and repair record and Feedback. This includes:
- Performing daily reviews of complaint, service, and repair cases to determine the need for Medical Device Reporting per 21 CFR 803.
- Maintaining the complaint database in our ERP system: IFS.
- Work with the Customer Service Representatives and repair technicians to communicate updates and satisfy customer needs.
- Tracking and updating statuses of all open complaints for trending and management review purposes.
- Ensure case records are completed in full and cases closed without undue delay.
- Readiness to pull completed records and present case details during external and internal audits.
- Act as the Document Control System Administrator. This includes:
- Ensuring adequate review, approvals, and training for all document changes.
- Ensuring the latest documentation is distributed to appropriate users,
- Ensuring obsolete documentation is removed from distribution, and all related documents are filed appropriately.
- Tracking and updating statuses of all document changes for trending and management review purposes.
- Perform quality assurance activities in support of designated quality processes such as:
- Record retention
- Training coordination
- Customer support
- Labeling and traceability
- Supplier management
- Perform ad hoc reviews of records to ensure system compliance.
- Participate in the preparation for Internal and External Audits.
- Support other department initiatives as directed by the Quality Manager.
Knowledge, Skills, and Abilities
- At least two years of relevant quality/regulatory experience in Medical Device or Pharmaceutical Industry or equivalent combination of education and experience.
- High School or Associates degree in a related field.
- Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook)
- Strong attention to detail.
- Ability to work in a team environment as well as alone with little direction.
- Excellent verbal and written communication skills to all levels of the organization.
- Strong organizational skills required.
- The position requires the ability to sit, stand, stoop, bend, and walk frequently during the shift.
- The position may require working extended hours or on weekends as needed.
- Incumbent may need to lift up to 30 lbs. on occasion.
If you are interested, please apply!
Job Type: Full-time
Pay: $55,000.00 - $56,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person
Salary : $55,000 - $56,000
