Night Shift Supervisor - Device Assembly

Location : Charleston, South Carolina, US

Reporting to : Head of Device Assembly

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide.

Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs.

Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

The Night Shift Supervisor Device Assembly will be a key team member in supporting the start-up and continued success of the Device Assembly Operations at a newly constructed state-of-the-art facility located in North Charleston SC.

The Supervisor will be an established professional with a passion for leading people and functional technical knowledge.

This is an Operations leadership role in of our new state-of-the-art device manufacturing facility in North

Charleston, South Carolina. The Superintendent will provide oversight and leadership for all departments on their assigned shift.

These functions include Manufacturing, Facilities, Supply Chain and Quality. with manufacturing systems.

Main Responsibilities

• Lead team of technical operators in Medical Device Assembly Operations
• Lead with a Safety-First mindset, proactively enforce all Safety Policies and Procedures
• On-Shift accountability for device assembly component Quality, pro-actively ensure all shift personnel are operating in
• accordance with all pre-established Quality Policies and Procedures
• Enforce strict compliance with current Good Manufacturing Practice (cGMPs) for all direct reports
• Be a Servant-Leader who remains present and available to your direct reports while on shift, maintain active floor
• presence time greater than 75%
• Be a critical and creative thinker who can process complex situations and make informed decisions
• Be a collaborative partner with your on-shift peers in Injection Molding, Metal Component Production, and Warehouse
• Operations
• Ensure constant training compliance of all direct reports, identifying skill gaps and organizing appropriate training
• programs to enhance team performance and capabilities
• Ensure operations and practices comply with established procedures and records
• Ensure in-process tests and inspections are performed in accordance with standard procedures
• Analyze and solve complex operational issues to minimize impact to overall performance of the operation
• Constantly improve technical knowledge of the assembly equipment for which you are responsible
• Support evaluation, specification, installation, and validation of new manufacturing equipment as needed
• Actively support Continuous Improvement functions
• Serve as project member or project leader on improvement programs as needed
• Willing to voluntarily take on additional task and responsibilities, as needed, to ensure the continued success of our
• operation as well as the company at large.
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable
• healthcare laws, regulations, and industry codes
• Be a Coachable, Servant Leader, with a results driven mindset, who is able to analyze complex situations,
• Review & complete evaluations of eDHR (device history reports)
• Provide leadership and coaching to department Supervisors
• Act as the primary liaison between night shift operations and daytime management, ensuring seamless communication and collaboration
• Support Site Leadership to build a diverse and capable site organization based in engineering first principles and operational excellence.

Talent management, development, and retention within the SHL Charleston organization (and beyond)

• Quickly address and resolve operational issues that arise during the night shift, making critical decisions to maintain workflow and productivity.
• Plan, coordinate and manage cost effective production strategies for assigned shift to meet production cost targets, schedules, and quality control standards
• Ensure strict adherence to current Good Manufacturing Practice (cGMPs), established manufacturing practices and procedures and compliance with Quality regulations and guidelines.
• Ensure operations and practices comply with established procedures and records
• Support evaluation, specification, installation, and validation of new manufacturing equipment as needed
• Incorporate value improvement programs and new processes from Engineering, EH&S, and OE as directed
• Serve as project member or project leader on improvement programs as needed
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes.

Skills and Qualification

• Bachelor’s Degree in (Engineering, Business, Operations Management) or equivalent experience or relevant concentration preferred required.
• Minimum 5 years relevant industry experience, strongly preferred in high-volume plastic and metal component assembly and production management / assembly automation and inspection technology
• Relevant experience in managing high volume manufacturing, including, material logistics, equipment maintenance and quality management.
• Several years of hands-on manufacturing experience in a 24 / 7 high-volume production setting.
• Proven experience in leading and managing teams in a high-pressure, fast-paced manufacturing environment.
• Passionate & committed self-starter with can do attitude, team player and taking responsibility to get the job done
• Ability to work independent with strong attention to detail and focus on efficiency, effectiveness, and cost.
• Willingness to work from / relocate to Charleston, South Carolina is required.
• Excellent intercultural and interdisciplinary communication skills; Good at building a professional network
• Previous exposure to a highly regulated industry (e.g., medical, pharmaceutical) and knowledge of relevant standards (e.

g., ISO13485, cGMP) is a major plus

• Experience with green field, or startup environment
• Experience within Manufacturing, Medical Device, Pharmaceutical, or Biotechnology industry
• Experience in developing, and implementing new processes or automating current processes.
• Willingness to initially spend an extended period in our facility in Taiwan for induction / training
• Functional knowledge and experience with MES and SAP systems

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents via the Easy Apply button or directly to [email protected] .

For more information on SHL Medical, please visit : linkedin.com / company / shlmedical / life

Is this not quite what you are looking for? Further interesting career opportunities can be found on : shl-medical.com / careers

Please note : For this position, we do not consider applications from recruitment agencies.