Job Description
Job Description
Quality Assurance Compliance Associate
1. Requirements:
a. GED or High School Diploma. Technical degree or minimum 3 years relevant experience in Quality, within extrusion or similar ISO13485/GMP manufacturing environment
b. Quality certifications (CQA), auditor training preferred
c. Proficiency in Microsoft Office
d. Basic understanding of QMS requirements
e. Familiarity with CAPA, root cause analysis
f. Experience with audits
2. Position Skills
a. Organization – Strong attention to detail and workflow interactions; able to adjust and maintain order and focus across shifting priorities
b. Critical Thinking – Able to effectively apply training, and assess and reconcile outcomes with defined requirements
c. Communication – Able to deliver clear and concise written and verbal communication
d. Mature work ethic –Technically independent, with ability to self-direct with minimal supervision
3. Reports to: Quality Manager
4. Primary job responsibility: QA Compliance Associate ensures processes and documentation meet QMS requirements, internal quality standards, and customer expectations. This position serves as a bridge between operations and quality systems to maintain effective and compliant workflows and Quality Management System (QMS) through continuous improvement. This position is performed with guidance and supervision with increasing independence consistent with training and experience.
5. Essential functions of position
Internal Audit Program
a. Support, facilitate and perform internal audits of processes, departments and systems
b. Perform auditing of key process areas by reviewing records, documentation, and work practices in accordance with defined procedures and requirements
c. Identify and document gaps in compliance, opportunities for improvement and observed risk in an internal audit report with support
d. Support external customer and certified-body audits
CAPA Process
a. Utilize the CAPA process effectively to address systemic procedural and/or process gaps and improvement opportunities within QMS
b. Perform and/or facilitate Root Cause Analysis for non-conformities
c. Initiate, facilitate, and compile all CAPA documentation and reports
d. Maintain, monitor and track CAPA log for workflow and process compliance
e. Work with Quality Manager in all aspects of the position to support organizational compliance with QMS requirements
Complaint Process
a. Support and/or perform the required activities within the Complaint and Feedback workflows for compliance, RCA, actions, and deliverables
b. Perform and/or facilitate Root Cause Analysis of reported complaints
c. Initiate, facilitate, and compile all required documentation and reports
d. Maintain, monitor and track Complaint log for workflow and process compliance
Communication, Reporting and Cross-functional Collaboration
a. Monitor and track workflow KPIs for reporting
b. Facilitate and contribute to the Complaint and CAPA meetings
c. Demonstrate effective communication across departments; interact and meet as needed with cross-functional members to facilitate compliance and completion of all aspects of the CAPA and Complaint process
Documentation and Compliance
a. Ensure compliance with applicable internal QMS, customer and ISO13485 requirements
b. Maintain accurate and complete records in all required documentation
c. Follow defined processes and procedures appropriately and effectively
d. Draft and revise applicable procedures as warranted
Growth and Development
a. Lead auditor / Internal Audit process owner
b. Soft project management
c. Workflow management and KPI reporting
d. Customer interface for customer complaint and feedback communication
Persistent: Standing: 10% Sitting: 75% Walking: 15%
Consistent lifting of up to 35 lbs. – Rarely
Minimum lifting of 1 lb. – Frequently
Maximum carrying distance of up to 30 ft. – Occasionally
Reaching – must be able to reach machines and/or materials up to 6 ft. from floor – Frequently
Kneeling – N/A
Climbing stairs – Occasionally
Repetitive motion – right/left hand/wrist – Frequently
Repetitive motion – right/left foot/ankle – N/A
Continuous arm motions – Yes
Must be able to avoid potentially moving object which could cause injury – Yes
Must be able to grasp and move object consistently and regularly – Yes
Vision: intricate nature of work requires vision of 20/20 with or without corrective lenses – Yes
Must be able to use gaging equipment and tools – Yes
Must demonstrate ability to work productively and efficiently with others – Yes
Microspec offers competitive wages and benefits including:
Sign-On Bonus
Comprehensive Health Insurance
Matching 401K plan annually after 1 year
Entry level 2 weeks paid vacation
64 Hours personal/sick time (unused time paid out at end of year)
Annual discretionary bonus
Salary range-$26-$32 per hour based on experience