Medical Manufacturing Manager
24401 Capital Boulevard Clinton Twp, MI 48036
Title: Medical Manufacturing Manager
Location: Clinton Twp, MI
We are in the process of a Medical Manufacturing Manager responsible for overseeing all medical validated manufacturing at company. This would include the management of employees (hiring/termination/discipline/performance management);
- Training of medical team
- Responsible for profitability, process and procedure compliance to 21CFR820 and ISO13485
- Required experience in ISO13485, GMP, GDP, DHR
- Working knowledge of plastic injection molding
- Assembly experience preferred
- Experienced manager of an injection molding team
- Owns the medical injection molding manufacturing client experience from the time the project is introduced at APQP through final part or assembly shipment.
- Responsible for the overall success and development of Our Clients’ s medical validated manufacturing operations medical team; this includes all resources utilized to develop repeatable processes, medical molded parts and assemblies in a compliant, safe, productive and profitable environment.
- Provides the strategic development and evolution of medical device manufacturing including development of volume production and assembly processes.
- Responsible for the profitability, quality, and timeliness of the manufacturing operation.
Work experience requirements:
- 10+ years’ experience in a senior management role.
- 7+ years’ experience with Quality systems such as ISO9001, ISO13485, ISO14971 and GMP, GDP and FDA, 21CFR-820.
- 5+ years’ experience in demand planning and finite scheduling in high-mix, low-volume medical device production environment
- 3+ years’ Cleanroom /medical experience (including IQ, OQ, PQ) highly desired.
- 5+ years’ experience with medical assembly operations desired.
- Must understand and adhere to good GMP and GDP practices, and understand the regulatory compliance associated with the medical device industry.
- Provide development and leadership of the medical injection molding and assembly operations including direct oversight of those disciplines that fall within the medical molding/scheduling, process/manufacturing engineer, maintenance and facilities, purchasing, shipping/receiving, and warehouse.
- Assuring that appropriate systems and structure are in place to produce acceptable medical device product that is packaged correctly to GMP and GDP standards.
- Personnel development of direct reports-- includes staffing recommendations, training, and APDA (associate development reviews).
- Taking appropriate action to improve Key Metrics (On-time delivery, gross margin, and cost of waste). Ensure that team provides reporting of metrics required for improvement.
- Coordinate with quality manager (who reports to the President) and quality team to ensure quality levels of product meet expectations and to support CAPA’ s.
- Customer Representative: Along with designated others, has the responsibility and authority to ensure that customer requirements are addressed.
- Accountable for development and leading the implementation of an annual medical operations plan, including an emphasis on structure, roles, automation of higher volume medical manufacturing and assembly including all auxiliary equipment needed for effective manufacturing.
- Assures inventory accuracy
- Departmental compliance to Our Clients BQMS.
- Safety of manufacturing work environment (compliant with state & federal requirements)
- Attend or have a qualified team member attend client meetings to review projects that are expected to have a significant financial impact to Our Clients.
- Provide plant layout and execute effective planning and implementation of the medical manufacturing.
- Driver for innovation and advanced technologies in manufacturing and assembly.
- Execute layered process audit
- Train team on lean, 5s, and appropriate best-in-class medical manufacturing processes that adhere to FDA regulations and ISO13485 requirements to cultivate an environment of continuous improvement.
- Determine and/or drive completion of medical manufacturing initiatives as set forth in quarterly and annual operating and manufacturing plans.
- Determine and manage manufacturing outsources.
- Other specified duties as required by the Director of Operations and engineering requirements.
- Live out Our Clients’ s principles (treat people professionally, helpful attitude, etc.)
- Own the client experience and profit plan for medical manufacturing.
- Own Gross Margin for medical molding/secondary/assembly.
- On-time delivery to committed dates
- Minimize Cost of Waste (COW)
- Provide a safe working environment
- Determine metrics that drive improvement of gross margin, OTD and COW.
- Stop any plant activity that is considered in violation of Our Clients, regulatory or safety requirements
- Approval of preventive and predictive maintenance plan
- Specify capital equipment needed
- Initiate training within approved budget
- Initiate process for dismissal.
- Initiate and implement disciplinary process up to final termination.
- Initiate hiring process.
- Spending within approved budgets.
Skills and Competencies:
- Strong communication skills: verbal, written and technical presentations.
- Working knowledge of statistics (e.g. Red X, Taguchi Methods, Disciplined Problem Solving, SPC Gage R & R) and production quality systems.
- Demonstrated ability to track improvement process through performance data.
- Strong organizational skills and the ability to successfully complete multiple tasks within established and changing deadlines. Excellent problem resolution skills.
- Working knowledge of Word, Excel and PowerPoint.
- Work performed in an office and manufacturing plant and Cleanroom environment. Normal mobility to move around an office environment, able to conduct normal amount of work at a computer.