Responsible for all people and processes necessary to manufacture Merit products at various facilities.
ESSENTIAL FUNCTIONS PERFORMED
1. Directs all facets of the facility, including Manufacturing, Materials, Quality, and Manufacturing Engineering.
2. Works with management team members from the corporation to ensure that customer needs are understood and met through Operations.
3. Resolves problems relating to all facets of the facility.
4. Handles and directs all Good Manufacturing Practices issues while ensuring that the highest degree of integrity is present in all processes and procedures.
5. Evaluates the performance of the facility in general and accepts feedback from department heads to make key organizational decisions.
6. Focuses resources for continuous improvement of site operations and quality.
7. Interviews and hires new employees involved in the operation's process.
8. Prepares site budgets and performs tasks involved in capital expenditure.
9. Evaluates and appraises the performance of employees to ensure that site needs are being met and objectives achieved.
10. Authorized to stop production or distribution of product manufactured at the facility if quality problems arise.
11. Ensures compliance with ISO requirements.
12. Performs a variety of related management tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
* Lifting -- Not to exceed 50 lbs. -- local practice may apply.
* Color perception
* Depth perception
* Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
* Education and/or experience equivalent to a Bachelor's Degree in Business, Engineering or related field.
* A minimum of nine years of responsible medical device and/or regulated manufacturing experience with a demonstrated ability to apply Good Manufacturing Practices (GMP) and meet ISO requirements at a multi-departmental level within a medium sized organization.
* Ability to work as part of a top management team.
* Demonstrated ability to meet organizational goals and schedules while making key decisions relating to the manufacturing process.
* Ability to make key decisions and set goals and objectives consistent with Merit's vision for production and product development.
* Ability to foresee obstacles which may stand in the way of future production needs and facility requirements to ensure that organizational expansion is possible as growth warrants.
* Excellent oral and written communication skills.
* Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
* Problem solving
* Organization performance evaluation
* Interviewing/hiring process
* Budget preparation/monitoring