Job description

Job Summary

The Quality Specialistis responsible for assuring that activities, processes, and specifiedconditions related to the daily manufacturing operations meet Current GoodManufacturing Practice standards and comply with applicable procedures andstandards to ensure the quality integrity of assigned product(s).

Essential Job Functions

· Coordinatesinspection, sampling, testing, and/or packaging of supplies/components andfinished products.

· Reviews SOPS, Forms, Work Instructions, etc. tomake sure most up-to-date versions are being used in Manufacturing.

· Effectively supports complaint handling process,non-conformance, internal/external audit and CAPA programs to ensure thesesystems provide adequate investigation and appropriate process modifications ina uniform and timely manner. Develop and prepare trend reports for complaints;NCRs, CAPAs monthly or quarterly as required.

· Assists QA Manager with all facets of StatisticalAnalysis data collection and analysis.

· Investigate and develop solutions toprocedure and process related issues. Defines process improvements.

· Participates indepartment and inter-department planning and management teams and workscross- functionally to improve processes within the organization.

· Identifies andobtains staff capabilities needed to accomplish objectives.

· Oversees andhandles projects that have short to long-term focus.

· Balancesplanning efforts with day-to-day demands.

· Communicateswith Vendor/Suppliers as necessary

· CoordinatesComplaint process with Customer Care Department

· Performs otherduties as directed by Manager or company management.

Qualifications

Education:

Required: High school diploma, TechnicalBackground; Preferred: BS degree: Scientific or Engineering Discipline

MinimumQualifications:

· A deep understanding of Quality Controlin manufacturing, preferably in medical devices.

· 2-3 years experience in Medical DeviceProduction FDA 21 CFR 820, ISO9001, ISO 13485 and other related FDAregulations.

· Working knowledge of cGMP audits fromFDA and other international bodies.

· High attention to detail

· Ability to work with all levels of management.

· Strong organizational, problem-solving,and analytical skills; able to manage priorities and workflow.

· Versatility, flexibility, and awillingness to work within constantly changing priorities with enthusiasm.

· Commitment to excellence and high standards.

· Excellent written and verbalcommunication skills.

· Proficient in MS Office (MicrosoftExcel, Word & PowerPoint) understanding of databases such as Access.

Job Type: Full-time

Pay: $45,000.00 - $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Work setting:

• In-person

Ability to commute/relocate:

• Newnan, GA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Required)
• Quality Assurance: 1 year (Required)

Language:

• English (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: In person

learninglandscape.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, learninglandscape.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, learninglandscape.com is the ideal place to find your next job.