Operations Specialist - Medical Device Manufacturing

Gilero, a Sanner Group Company, is growing and looking for an Operations Specialist to support manufacturing of exciting assembly automation projects for medical and pharmaceutical delivery devices at our Pittsboro, NC manufacturing plant. You will be responsible for production planning, lot review, non-conformances, deliveries, and production metrics. If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence! Responsibilities Oversee daily production reporting and compare to standards (OEE). Maintain MRP functions related to Sales Orders, Work Orders, inventory management, and new product setup. Coordinate with Customer Service/Supply Chain Manager on the production schedule. Ensure the execution of production programs according to schedule, quality standards and forecasted expenses, to satisfy sales needs, by coordinating activities of the plant and without compromising the future of the plant. Achievement of production and shipping commitments. Achievement of product quality commitments. Achievement of cost commitments (budget and forecasts). Achievement of outstanding safety performance Responsible for accuracy of production reporting and material consumption rates. Manage the project improvement tracking and assist project leaders to develop tracking mechanisms for ongoing reporting. Develop and implement a plant communication plan for process improvement efforts. Implement, maintain, and update applicable QMS system documents. Oversee corrective and preventive actions issued to production. Participate on the Management Review Board (MRB) Team for Nonconformance Report (NCR) disposition, sorting, and corrective actions. Work with Design Engineering on scheduling, resources, and execution of pilot builds. Maintain and drive compliance to applicable QMS systems on the production floor. Participate in Design Transfer meetings to help identify the handoff between Design and Production. Maintain a production schedule that allows for all preventative maintenance activities to be performed. Collect data and report back to Quality and Customer Service on supplier issues with purchased parts. Identify areas for improvement based on daily reporting. Support ad hoc projects and operational initiatives as needed.

Skills/Qualifications:

4-year degree in a technical or business-related field 5+ years of experience in Operations Advanced knowledge of MRP System functionality Knowledge of medical device regulations (FDA/ISO), preferred Excellent communication skills, attention to detail, writing skills and data analysis skills Project management skills and ability to work alone or in teams Ability to communicate effectively with customers and suppliers in a technical capacity Excellent computer skills

Personal Attributes:

Meets Gilero Core Values:

Collaboration, Innovation, Excellence, Integrity Productive in a fast-paced, entrepreneurial environment. Commits to excellence and quality service to external and internal customers. Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work:

Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future. Gilero does not offer sponsorship for employment authorizations (work visas). We are an E-Verify employer and confirm work authorization for all new hires. Why work at Gilero? Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro. Gilero's Pittsboro facility is located in downtown Pittsboro within walking distance to multiple restaurants, breweries, boutique shops, and entertainment. You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.