Responsibilities include direct management of 20-50 Manufacturing Technicians and other hourly personnel, fulfillment of the production schedule, and ensuring quality compliance. Provide operations expertise, and technical skills to the supervision and support of manufacturing personnel to achieve New Product Development, Continuous Improvement, Quality, Compliance and Operational metrics.
- Supervise production personnel and activities to effectively support manufacturing needs to meet customer requirements for existing commercial products, new product introductions and R&D builds.
- Hire, train, develop and evaluate production personnel to ensure the appropriate resources and talent are in place.
- Plan and schedule resources and activities to ensure business needs are satisfied.
- Tracks, analyzes, summarizes and reports key indicator data and metrics for areas of responsibility.
- Evaluate direct reports performance on an annual basis in a written performance review.
- Responsible for ensuring compliance to quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies. Includes the diligent management of non-conformances to ensure appropriate corrective and preventive actions.
- Proactively identifies potential failure modes relative to quality or business risks.
- Collaborate and provide manufacturing input and support to New Product teams, including the design for manufacturing (DFM) guidance, input on process / tooling development and developing/refining manufacturing instructions.
- Collaborate with Supply Chain, Logistics, Manufacturing Engineering and Quality to drive value stream and lean manufacturing improvement initiatives.
- Provide technical guidance and input regarding new processing strategies and associated equipment procurement.
- Identify and implement lean manufacturing opportunities in effort to improve quality, increase productivity, reduce costs and reduce cycle times.
- Develop and sustain the manufacturing team as a quality minded culture driven by focusing on customer service (external and internal), outstanding compliance, continuous improvement activities that support business objectives.
- 20-50 Manufacturing Technicians and other hourly personnel
- B.S. degree in Engineering or Science.
- Minimum of 6 years of related experience in the medical device, pharmaceutical or similarly regulated industry.
- 2-4 years’ experience in Technical Supervision and/or Engineering in the medical device or pharmaceutical industry.
- Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).
- Experience working with a clean room environment, and application of environmental procedures.
- Experience working with manufacturing/MRP systems (QAD preferred)
- Experience and/or certification in LEAN Manufacturing principles.
- Experience and prior training (or ideally certification) with Lean Manufacturing and/or Six Sigma methodologies. Experience with Statistical Process Control a plus.
- Must be a hands-on, self-directed, organized and conscientious individual
- Complete work in a timely, accurate and thorough manner
- Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMark’s business
- Effective analytical problem solving and decision making skills
- Strong time management and organizational skills in a dynamic, constantly changing environment
- Strong communication skills including the ability to communicate with all levels within the organization