Our client company in Trumbauersville, PA Is looking for a Quality Control Engineer!

BASIC FUNCTION:

Works closely with the Quality Assurance Manager to ensure quality production of products consistent with established standards by performing the following duties personally or through subordinate employees and supervisors.  Develops and maintains the company Internal Audit Program.

The Quality Assurance Engineer ensures compliance to all applicable statutory and regulatory requirements. The Quality Assurance Engineer receives sufficient authority from and is accountable to the Quality Assurance Manager for the successful completion of assigned duties and responsibilities.

REPORTING RELATIONSHIPS:

Quality Assurance Engineer reports directly to the Quality Assurance Manager. This position does not supervise any direct reports

DUTIES AND RESPONSIBILITIES:

The principal duties and responsibilities of the Quality Assurance Engineer consist of, but are not limited to, the following:

Ensures company-wide compliance to 21CFR 820, ISO 9001, ISO 13485 regulatory requirements and promote awareness of regulatory and customer requirements throughout the organization.

• Reports to top management on the performance of the quality management system and any needed improvements.
• Investigate and conduct root cause analysis for customer complaints, internal non-conformances and corrective actions due to audit findings.
• Perform risk analysis and risk management tasks as needed.
• Ensure processes needed for the quality management system are established, implemented and maintained. Develop, review and submit for approval production, inspection, packaging, set-up, start-up and processing / assembly instructions.
• Design and implement quality assurance training programs to key personnel in conjunction with other department heads.
• Applies statistical process control (SPC) and other methods for analyzing data to evaluate the current process and process changes.
• Develop and maintains company internal audit programs. Performs internal audits per schedule ensuring compliance to all applicable requirements and the quality management system.
• Develops quality objectives at all relevant operations and reviews all data obtained through monitoring and measurement activities to ensure product quality and processes are consistent with company policies and procedures and regulatory requirements.
• Develops new approaches to solve problems identified during quality assurance activities.
• Manages, develops, reviews and approves, and executes process validation protocols, engineering studies, equipment qualifications.
• Maintains a working knowledge of government and industry regulations and standards.
• Review, analyze and summarize quality databases for trends.
• Any other activities / tasks assigned by immediate supervisor or management.

MEASUREMENT OF PERFORMANCE:

The Quality Assurance Engineer shall be deemed to be performing in a satisfactory manner when the following have been met and / or exceeded:

•  Goals Outlined on the Company Metrics and Quality Objectives stated on the Measuring, Monitoring and Analysis Table (QMSMMAT).
•  Overall satisfaction of immediate

REQUIREMENTS:

EDUCATION:

Preferred:  Bachelor's degree in Quality Assurance from four-year college or university; or one to two years related experience and / or training; or equivalent combination of education and experience in the plastics industry. Quality certifications from organizations such as American Society for Quality (ASQ).

Required: Bachelor’s Degree in related field or one to two years related experience and / or training; or equivalent combination of education and experience.  High School Diploma / GED.

7.2 SKILLS:

• Analytical - Synthesize complex or diverse information; Collect and research data; Use intuition and experience to complement data; Design work flows and procedures.
• Problem Solving - Identify and resolve problems in a timely manner; Gather and analyze information skillfully; Develop alternative solutions; Work well in group problem solving situations.
• Project Management - Develop project plans; Coordinate projects; Communicate changes and progress; Complete projects on time and within budget; Manage project team activities.
• Planning / Organizing - Prioritize and plan work activities; Use time efficiently; Plan for additional resources; Set goals and objectives; Organize or schedule other people and their tasks; Develop realistic action plans.
• Judgment - Display willingness to make decisions; Exhibit sound and accurate judgment; Support and explain reasoning for decisions; Include appropriate people in decision-making process; Make timely decisions.
• Communicate quality goals, plans, actions and results to different audiences, such as customers, suppliers, employees and managers. Explain concepts and technical details in a clear and concise way. Actively listen, give and receive feedback, and persuade and influence others.
• Quality - Demonstrate accuracy and thoroughness; Look for ways to improve and promote quality; Apply feedback to improve performance; Monitor own work to ensure quality.
• Coach, teach, and communicate with Supervisors / Managers and subordinates. Strong (effective) written and verbal communication skills to interact with people at all levels.
• Office Skills - Uses computer, variety of software programs, and various office equipment and has ability to train others.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to hours of work necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Ability to work independently with little direct supervision

PHYSICAL:       This position requires the ability to listen and hear, good eyesight, sitting, standing, walking, and use of hands and arms. May be required to occasionally lift and / or move up to 25 pounds. Use small tools, equipment and fixtures with hands.

MENTAL:  Must be able to read, write and speak English. Ability to define problems, collect data, establish facts and draw conclusions.

WORKING CONDITIONS:

Although this position will primarily be an air-conditioned office environment, may be required to work throughout the plant in non-air-conditioned situations. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually quiet to moderate. Employee is required to wear hair nets (and beard nets when applicable) as specified in the Employee Handbook. Employees must follow dress code as detailed in the Employee Handbook. Employee is required to adhere to the company's Code of Conduct.

WHY WORK FOR ONESOURCE STAFFING?

-Gain Access to our Vast Network of Client Connections
-Weekly Pay
-One-on-One Staffing Manager support

OneSource Staffing Quakertown
25 Quakers Way
Quakertown, PA 18951
Phone: 215-631-9500

Apply at www.onesourcestaffing.com