We are currently seeking a QA Manager who will be directly responsible for leading and directing the Quality team to implement, monitor, and improve all company quality systems to demonstrate compliance with ISO 9000/14001 requirements.
Key Responsibilities Include:
1. Design, implement, and continuously improve the Quality System - create the overall system architecture, optimize the Quality Manual and the SOP structures, establish key business processes and align the quality system to them, establish a risk assessment process.
2. Be the "Quality Face" to our customers - establish ongoing communications with customers regarding requirements, company performance, and future expectations. Work with Sales & Marketing to perform formal customer surveys.
3. Act as the Compliance Officer - assure internal compliance with established procedures, create and execute an internal audit program, prepare the organization for and host customer, certifying body, and regulatory agency audits. Assist Supply Operations with supplier audits.
4. Own certain key decisions/processes - material disposition decisions, rework process approvals, final product release, assignment of material status (quarantine, etc.), shipment holds, and others as designated.
5. Lead quality engineering, drive QE principals into the organization - establish and supervise the quality engineering function, including validation programs, customer complaint investigations, statistical validity assurance and metrics analysis.
6. Lead the quality assurance functions - establish as needed and execute programs for change control, deviation control, calibration, tooling & fixture control, customer complaint handling/tracking, records management, and corrective and preventive action assignment and tracking.
7. Design and implement a comprehensive training program - identify core curriculum for various job functions, establish training requirements & tracking, establish operator qualification programs.
8. Conduct Management Reviews - establish and lead the formal Management Review process.
9. Support improvement projects and teams - provide appropriate support for continuous improvement projects, e.g. Kaizen/lean initiatives, supplier quality improvements, 5-step method for problem resolution on the production floor, etc.
10. Other duties as specifically assigned.
We welcome all qualified applicants who who would like to join a dynamic, growing company that offers friendly, clean work environment with hands-on input, challenges and growth opportunities.
Candidates must be a U.S. citizen or a permanent resident. We do not offer practical training positions nor sponsor foreign citizens to obtain work visa or permanent residency.
Excellent benefit program:
Insurance: Health, prescription drug, dental, life, disability, Long Term Care. Retirement.
Leave & Holidays: Sick,Personal, vacation, paid holidays.
Successful candidate will possess:
- Bachelor of Science Degree in relevant discipline or equivalent in experience.
- 5 to 7 years of work experience in the quality discipline in a manufacturing organization or as a consultant to a manufacturing organization.
- Knowledge of Radiation Safety and EHS principles.
- Experience with manufacturing or device component manufacturing, or other manufacturing.
- Working knowledge of inspecting parts.
- Experience with implementing, maintaining, and improving process validation programs and change control programs.
- Excellent leadership, communication and computer skills.
For immediate consideration, please forward a copy of your current resume to xxx@xxxxxxxxxxxxxx.xxx referencing job #5826. |