Description
The company is looking for someone who places culture as high on their list when considering their next opportunity. Having won awards for best place to work, they pride themselves on getting the right people. Furthermore the job is for a creative candidatie who enjoys forming their own sysmtems and is ready wear 'multiple hats'. This will have all the feel of a start up with out the pitfalls due to large company backing.They are seeking an individual with BS or high in Engineering (industrial, mechanical, chemical, etc.) with 7+ years' experience to supervise the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant.
Duties and Responsibilities:
- Management and development of staff; ensure that CAPA, supplier/internal audits, calibration system, supplier development engineering, quality engineering, and complaint handling are staffed with qualified employees; ensure that direct reports are appropriately trained and have resources to do their assigned tasks; provide reports with career development opportunity.
- Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements.
- Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development.
Preferred Skills:
- Leadership and management skills.
- Regulatory, 5-10 experience with ISO13485 and FDA QSR
o Quality system oversight.
o Class II and above IVD (or medical is acceptable).
o Design controls oversight.
- Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison).
- Computer literate (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.).
- Negotiation and problem solving skills.
- Ability to operate and communicate effectively with multiple teams.
- Supplier auditing skills (i.e. ASQ-CQA, internal/external courses, seminars).
- Able to understand blue prints, tolerance analysis and related knowledge.
Reasoning ability, support and prioritize projects, adapt to many situations.
If this sounds like you then please upload your cv now or cal Andrew at Real Staffing on