Director, Operations
On-siteQuakertown, Pennsylvania, United States
Job Summary
Direct and oversee all Medical Component and Technical Textile manufacturing operations, including prototyping, yarn preparation, weaving, knitting, and braiding, ensuring safe, efficient, and compliant production. Lead continuous improvement efforts across the organization by driving root cause investigations, implementing lean manufacturing principles, and optimizing processes to enhance yield, quality, and profitability. Provide overall site leadership for the Perkasie and Quakertown facilities, managing workforce planning, capital projects, and facility stewardship while serving as the primary point of contact for customer interactions, audits, and regulatory inspections. This role requires a minimum of 10 years in regulated manufacturing, with 4 years in management, and a Bachelor's degree in engineering. The position reports to the Solesis family of companies and involves strict adherence to ISO 13485, GMP, and safety protocols.
Required Qualifications
- Bachelor's degree, preferably in an engineering discipline
- A minimum of 10 years' experience, including experience in regulated manufacturing environment, preferred textile and medical device industry
- A minimum of 4 years' experience in a management role
- Demonstrated leadership skills and the ability to coach and mentor staff
- Must have considerable knowledge of manufacturing processes
- Knowledge of machinery, equipment, tools and textile equipment in support of yarn preparation operations, specifically as it applies to winding, twisting, direct and indirect warping
- Possess knowledge of ISO 13485, 9001 and GMP practices or possess the ability to understand and enforce the practices
- Ability to follow and make recommendation and changes to WI's and SOP's
- Ability to measure in all units of measurements and possess a high mathematical aptitude
- Considerable knowledge of ERP systems and the manufacturing workflow
- Considerable knowledge of the Microsoft Suite of products, specifically Excel, Word and Outlook
- Good presentation skills and the ability to present on a one-to-one basis and to small groups
- Ability to manage a technical project, understanding the client's needs, how the needs relate to the scope of the project and how changes will affect other systems
- Proven success in leading projects, delegating tasks, setting priorities and delivering results
- Demonstrated ability to lead and work effectively in cross functional teams and across businesses
- Strong cross-functional perspective, leadership and influencing capbilities within a matrix organization
- Comfortable working in a fast pace environment with firm deadlines
Desired Qualifications
- experience in regulated manufacturing environment, preferred textile and medical device industry
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