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Job Description

We are looking for a Director of Operations and Production Manager to join our client's team in Cary, NC. Out client is a producer of endoscopes in the medical device industry. The Director of Operations and Production Manager is responsible for ensuring the production schedule is completed in a timely manner within quality assurance (QA) parameters by directing a Quality Manager and (2-3) production assembly team members and scheduling workflow to fulfill requirements. This position provides operational training to the assembly team and feedback to the company President. This individual ensures safety and quality standards are maintained and compliant with FDA guidelines. They drive continuous improvement and problem solving within their production team and can also perform all job functions within the assembly area.

Responsibilities:

Direct production assembly team and schedule workflow to fulfill requirements, ensuring that production is completed in a timely manner and within quality parameters

Coordinate and emulate all processes and activities as established in company's European headquarters

Drive troubleshooting and problem-solving activities within a dedicated production area when target performance is not achieved

Work with company President to manage and prioritize department assignments to ensure production schedules are met

Perform and follow QC (quality control) inspection of products standards

Coordinate employee training with European HQ, or another department to ensure that procedures are followed and meet all quality and safety requirements

Participate as an active member of the assembly team and support team when required

Provide the team with personal protective equipment (PPE) and ensure employees adhere to proper usage of equipment and follow all company safety policies and regulations

Report problems or concerns with quality, processes, equipment, materials or labor to company President

Work closely with supporting staff such as Shipping & Receiving, Manufacturing Engineer in Europe, external vendors (packaging and sterilization), and others, etc. to resolve issues and answer questions

Actively participate in cycle counting and inventory accuracy within your department to fulfill all Inventory control and internal auditor team requirements

Escalate labor shortages to the company President and provide input into the performance of team members as assigned

Coordinate regular employee team communication and training of required procedures regarding work assignments, safety, quality, and their performance

Annually perform performance reviews and improvement plans with each team member reporting to this position and providing feedback to Company President

Measure, chart, and monitor predefined performance metrics and provide reports as needed

Maintain a safe and clean department, adhere to all safety regulations and communicate regularly with colleagues in Europe

Follow documented QA/RA policies and procedures as designated by quality standards

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

5-10 years of experience in production assembly or manufacturing, ideally in packaging and sterilization

Leadership experience, experience managing a team

Experience with manufacturing forecasting and planning

Experience communicating with external vendors

Ideally experience working in a clean room environment at a medical device company null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].