We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you'll do:
- Oversee manpower assignments in the Quality Assurance Department.
- Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.
- Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
- Oversee maintenance of the ISO 13485 and FDA QSR compliance process at the division level.
- Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals.
- Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program.
- Review current quality systems and develop alternate, more efficient processes.
- Interface with customers on technical/quality issues and improvement initiatives.
- Responsible for managing customer audits and regulatory/compliance agency audits.
- Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.
- Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
- Responsible for establishing and maintaining departmental operating and capital budgets.
- Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
- Ensure departmental training needs are fulfilled.
Here is some of what you'll need (required):
- 8 + years of experience developing, implementing, and maintaining quality systems
- Experience in an ISO 13485-2016 documentation control environment, with experience preparing and controlling work instructions and process control documents
- Prior experience with heavy customer interfacing and helping solve customer complaints
- Experience with NCR, SPC, and part inspections
- FDA QSR compliance maitenance
Here are a few of our preferred experiences:
- Knowledge and experience with ISO14000
- Experience with Injection molding
Here are a few examples of what you'll get for the great work you provide:
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
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