Summary: Supervises, coordinates, and directs the activities and functions of the Quality Control Inspection Group by performing the following duties personally or through subordinate employees.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
1. Supervises and coordinates inspection activities for materials received, in-process inspection, Final Acceptance Testing, and off-site inspection activities.
2. Ensure department personnel, supplies and equipment is available to efficiently and effectively perform quality inspections.
3. Develops and maintain inspections plans.
4. Implements and enforces all ISO and FDA regulations applicable to manufacturing.
5. Performs training and completes records of same for subordinates and others as required to meet training needs identified by the Quality Assurance Manager. Such training includes, the use of all gauge components (i.e., calipers, comparator, micrometer, ball micrometer, scales dial gauges, special gauges, etc.) and testing equipment that relates to inspection of incoming material.
6. Directs workers in quality assurance inspection to assure that establishment, quality and regulatory standards are met.
7. Oversees, coordinates, and schedules on-site customer or government source inspections; maintains business relationship with third party inspectors for government and various commercial customers.
8. Participates as an Internal Auditor of the company’s Quality Management System.
9. Coordinates internal and supplier evaluation, investigation, and corrective action activities as needed.
10. Schedule and submits test samples for independent verification and/or testing; coordinates receipt of results, certification and authorization to release materials/products based on results.
11. Provide assistance with calibration for all inspection equipment used in manufacturing and inspection as needed.
12. Partners with management on product performance, long term planning and problem resolution.
13. Reviews and properly interprets simple to complex drawings and specifications applicable to company products.
14. Leads subordinates with a strategic vision and steps necessary to achieve both
Short-term and long term departmental and company goals.
15. Complies and enforces company policies, practices and procedures.
16. Authorizes material transactions in the ERP system.
17. Works effectively and communicates clearly with other employees and other departments.
18. Handles changing deadlines and priorities to meet required department output.
19. Reviews its own work and that of subordinates for accuracy, completeness, and proper authority.
20. Serves as a Quality Management Representative and approves documents as standard operative procedures permit.
Directly supervises a team of as many as six employees in Inspection. Enforces and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include, but not limited to; interviewing, selecting, training, disciplining employees; planning, assigning, determining, and directing work; providing input and assisting in performance appraisals, addressing employee complaints and resolving problems. Is assigned the duty and responsibility of Quality Management Representative by the QA Manager as required and where applicable per standard operating procedures. Provides for the safety of employees and company property.
- Decision Quality
- Customer Focus
- Managing Vision/Purpose
- Values and Ethics
- Delivers Results
- Develops People Capability
- Technical Skills
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Certified ISO 9001 and/or ISO 13485 Internal Auditor desired, but not required.
- Proficient with standard and complex measuring and test equipment
- Ability to read and comprehend basic component drawings, complex assembly drawings, test procedures, and schematics.
- Ability to perform all inspection duties, provide technical support, and report findings
- Basic knowledge and understanding of sampling techniques (ANSI/ASQC Z1.4).
- Knowledge of established rules of metrology including basic working knowledge of geometric dimensions tolerance; ASME Y 14.5 – preferred.
- Must have good manufacturing practices, experience with Cleanroom/White Room working environment is a plus.
- Effectively works in a team setting, facilitates communication, and coordinates conflict resolution within and among work groups.
Education and/or Experience
Associate’s degree (AA) preferred and 5 years’ related experience or 10 years of demonstrated, direct quality assurance control experience in an ISO 9001 and/or AS9100 work environment.
Strong communication skills both written and verbal. Ability to read and comprehend instructions, correspondence and memos. Ability to effectively present information in one-on-one and small group situations including; subordinates, customers, clients, and other employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Able to apply statistical methods for accurate sampling, analysis and reporting. Ability to convert between fraction and decimals and percentages.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several variables in standardized situations.
Proficient in MS Office applications (i.e., Outlook, Word, Excel, etc.), ERP System – EPICOR is a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is occasionally required to sit and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the work environment is usually moderate.
Reasonable accommodations may be made to enable individuals to perform the essential functions.
PCI is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. PCI is also a federal contractor. Employment may be contingent upon U.S. citizenship or valid “green card” holder status.Apply Now