MQA and Document Control Manager

Plas-Tech Engineering is a growing medical manufacturer that makes its employees and customers their #1 priority. As our company continues to expand, we are looking to add motivated and enthusiastic individuals to our team. If you are searching for a company that is exponentially growing, centered around customers, and caring about its employees, PTE may be the right company for you!

Position Summary:

This position is responsible for the organization, administration, and supervision of 1-5 QA Document Control Specialists and oversight of the day-to-day operations for Manufacturing Quality Assurance/Manufacturing Quality Control/Documentation Control. This includes document handling and providing oversight for Quality and Manufacturing/Operations Document Systems. Responsible for: Document Change Request (DCRs), MQA (Manufacturing Quality Assurance) Batch Records and DHRs, Document Control, and finished DHR (Device History Record) GMP/GDP compliance.

Essential Functions:

1. Responsible for the operation and functions of the MQA/MQC/DC department and QA/QC documentation specialist group which includes interfacing with Materials Management/Inventory Control, Engineering projects, Validation, Stability, Manufacturing, technical transfers, NC/CAPA, Training and Customer initiatives.

2. Evaluations of batch records, device history records, laboratory data records, and approvals of records for release and disposition.

3. Evaluation and retention of batch records, device history records, training records, testing records, and forms for GMP compliance.

4. Filing records and maintaining the Document Control Library in control with external and internal customer expectations for timeliness and retention.

5. Identifies results of testing and proposes nonconformance and implementation of CAPA.

6. Assists with authoring, changing, and updating procedures and records for all functional groups and departments (operation, calibration, training, QA/QC, MQA/Document Control, engineering, etc.)

7. Responsible for quality reviews and quality assurance of documentation for all functional groups and departments.

8. Responsible for authoring, writing, reviewing, and maintaining QA/QC MQA/ Doc Control procedures, forms, and records.

9. Responsible for collaborating with functional groups on writing, proofing, error proofing, and publishing Quality Management System policy, procedures, records, and forms.

10. Responsible for compliance of all documentation and records according to 21 CFR Part 820 Subpart D and Subpart M, and adherence to ISO 13485:2016.

11. Assists in the periodic inspections of document control areas, laboratory areas, and manufacturing areas to ensure that they are operated and administered according to GMP/GLP procedures and safety requirements. Accomplished by coordinating with the Quality and Compliance Manager and collaborating with cross-functional teams.

12. Lead project teams in the document control and quality departments related to MQA, QA/QC efficiency and improvement.

13. Responsible for the management and oversight of the Quality and Document Control Specialists and Technicians. This will include: hiring, setting performance expectations, providing performance feedback, developing of staff, and handling personnel issues.

14. Maintain metrics for tracking and trending of QA/QC, MQA, and Document Control programs.

15. Maintain a proceduralized and compliant library of internal and external customer specifications and requirements.

16. Assist with Engineering Change Control and Change Notifications to and from customers and suppliers.

17. All additional duties as directed and required by the Director of Quality and Regulatory Affairs.

Position Requirements:

Education and Experience

A Bachelor of Science (in science or engineering preferred) and 4 years of experience in a medical device or pharmaceutical industry preferred. OR an associate degree in science with 8 years of experience in the same type of industry setting will be considered. A high school diploma with 10 years of equivalent experience in the medical device or pharmaceutical industry will also be considered.

Experience in the plastics industry is a plus. Experience with GXP (GMP and GDP) regulated production processes is required. Must demonstrate skills to deal effectively with all team members and colleagues. The ability to collaborate is a must. Excellent problem-solving skills with the ability to effectively use tools associated with ensuring compliance and quality documentation.

Familiarity with calipers, micrometers, depth micrometers, indicators, gage pins, gage blocks, height and pin gages, coordinate measurement machines (CMM), and/or precision optical equipment is a plus. Must have the ability to manage others. Experience with ISO 13485 is highly preferred.

Qualifications

Required to have strong written and verbal control of the English language, the ability to communicate effectively with other departments, and can be clearly understood. The ability to add, subtract, multiply, and divide all units of measure, including whole numbers, common fractions, and decimals is required. Must have the ability to compute rates, ratios, and percentages, as well as develop and interpret graphs.

Must have intermediate to advanced computer skills, especially with Microsoft Office applications, and a strong background in ERP systems. The ability to effectively prioritize, organize, multi-task, and be detail-oriented is required. Must be able to meet deadlines, follow through on commitments, and take corrective action where appropriate.

Certifications such as CQE, CQA, CQM, 6 Sigma (black, green, yellow), cleanroom, trainer, or others are a plus.

Additional Requirements

Must be able to stand, walk, and sit most of the time. Light to medium physical activity, non-strenuous, will be performed daily. Must be able to work with hands and fingers and have the ability to see, identify, and distinguish colors.

Work Schedule/Hours

On-site, Monday through Friday, 7 am to 5 pm. Must be available some weekends as needed.

Reports to
Director Quality and Regulatory Affairs

Job Type: Full-time

Pay: $80,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• Overtime

Experience:

• Microsoft Office: 8 years (Required)
• medical device manufacturing: 4 years (Required)
• Precision measuring instruments: 8 years (Required)
• FDA regulations: 4 years (Required)
• ISO 13485: 4 years (Required)

Work Location: In person

Salary : $80,000 - $95,000