Operations Supervisor
Full Time • Irvine
Experience: 3-5 years of production supervisor/lead experience, with 2 year of medical device manufacturing experience.
Location: Local candidates only (must live in Orange County)
Job Type: Full Time, 100% In-House
Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, , Company Parties
Principal Duties and Responsibilities
- Ensures scheduling of staff to fulfill day-to-day production as needed.
- Adjust production technicians to prioritize and daily goals to meet changing demands.
- Maintain production schedules and allocate resources effectively to meet production targets and customer demands.
- Monitor key performance indicators (KPIs) related to production output, quality, and efficiency, and take corrective actions as necessary to meet targets.
- Prepare production reports and communicate production status updates to management as required.
- Provides direction, supervision and assignment of the workload balance and prioritize activities based on urgencies or business requirements.
- Responsible for actively working with all departments within the organizations to manage and address urgent requests and investigate customer/distributor inquiries.
- Works closely with Quality to ensure only released material is placed into inventory and delivered to the production floor.
- Provide leadership to accomplish continuous improvement in quality, cycle time and total cost by advocating and driving the use of process excellence methodologies (six sigma, lean, etc.) within operations.
- Ability to master all clean room production processes.
- Adhere to the applicable rules & guidelines set within the company and ensure they are followed.
- Adhere to all QMS and ISO Standards. Ensure all department procedures are followed and quality records maintained.
- Develop and motivate a high performing team of both direct and indirect reports driving to achieve a common set of goals to provide high quality products to our customers.
- Ability to master all clean room production processes.
- Ability to train and develop production staff to ensure competency and adherence to standard operating procedures.
- Maintain the Training Matrix used to track individual training progression and provide a snapshot of individual qualifications.
Skills and Qualifications
- Must possess a strong leadership track record, proven management competence in a fast-paced environment and active cultural change.
- Minimum of 3 years in a lead or supervisory role experience
- Minimum of 2-year previous experience in manufacturing medical devices
- Working experience in clean room environment
- Proven ability to interact and effectively communicate with peers, business partners and suppliers.
- Must be organized, detail-oriented, and driven with the ability to prioritize multiple competing projects.
- Lean background is a plus.
- Knowledge/proficiency Microsoft Office, spread sheets, production planning, inventory management, and data base systems
- Experience working with FDA and CE approved medical devices, example- long term human implants
Compensation: $70,000.00 - $100,000.00 per year
Lives well bridged - Indeed!
We bridge lives by offering innovative & well thought out solutions to the medical device industry
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies. Often times working with our partners we can help our clients with stent, delivery system & FIH clinical trials also.
We have the unique talent of manufacturing, consulting, and strategizing services in the area of medical devices, especially transcatheter heart valves. Our specialty is customizing the solutions required based on the device and not recommending the whole “nine yards” for any device, thus saving our clients’ time and resources.
Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We come with an in-depth knowledge with many years of experience and offer customized solutions to each of our clients on an as needed basis with the utmost integrity.
(if you already have a resume on Indeed)