Qualomics LLC Hiring for Medical Device Quality Assurance Associate Job at Remote Full Time

Full Job Description

JOB SUMMARY:

Qualomics LLC is a leading provider of quality assurance services to small and mid-size medical device companies. Our mission is to support clients in development and management of their quality management systems. This role will support multiple clients and requires some project management skills. This individual will also be responsible for maintaining a culture of continuous improvement.

RESPONSIBILITIES:

• Work independently to:
• Perform document/change control activities
• Review revisions for consistency and format as needed
• Process Change Requests – provide documents as requested, prepare and issue routing packages
• Close out routing packages
• Maintain detailed Excel log of all change request activities
• Prepare and track training records

• Assist with:
• Corrective and preventive action tracking
• Complaint tracking
• Updating SOPs and forms
• Vendor and/or supplier qualification
• Internal and external auditing
• Preparation for management review meetings

REQUIREMENTS:

EDUCATION:

• Bachelor’s degree in a life science or engineering field preferred. Commensurate experience will be considered.

KNOWLEDGE AND EXPERIENCE:

• At least 2 years cGMP or ISO 13485 quality management systems experience.
• Experience in laboratory or manufacturing operations.

SKILLS AND ABILITIES:

• Project management skills to ensure quality records are complete
• The ability to manage multiple deadlines and deliverables at one time
• Experience in life science, medical device, pharma, or biotech industries
• Intermediate to advanced skills in Word and Excel
• Extremely detail-oriented
• Good written and oral communication skills

PROBLEM SOLVING AND DECISION MAKING:

• Develops solutions to a variety of complex problems; ensures solutions are consistent with organization objectives.

PHYSICAL REQUIREMENTS:

• Ability to hear and speak to employees and external associates on the phone and in person.
• Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision).

TRAVEL REQUIREMENTS:

• May require travel to and from customer/vendor locations.

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.

Job Type:

• Part-time
• 20 hours per week. At least 15 hours per week are to be scheduled Monday through Friday during normal West Coast (Pacific Time Zone) business hours.
• Remote work. Office is located in Carlsbad, CA.

Job Type: Part-time

Pay: $32.00 – $40.00 per hour

Benefits:

• Flexible schedule
• Professional development assistance

Schedule:

• Monday to Friday

COVID-19 considerations:
This is a remote opportunity.

Application Question(s):

• Although this job is remote and posted nationally, this job requires you to work during normal business hours in the Pacific Time Zone. Are you willing to schedule your time in Pacific Time?

Education:

• Bachelor’s (Preferred)

Experience:

• Quality assurance: 1 year (Preferred)
• laboratory operations: 3 years (Preferred)
• Manufacturing: 3 years (Preferred)

Shift availability:

• Day Shift (Required)

Work Location: Remote