Director Quality Operations Jobs in Rochester, IN

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics' global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.
GENERAL SUMMARY: The Senior Supplier Quality Inspector is responsible for performing advanced product quality inspections directly at Orthopediatrics' supplier locations. This role serves as an on-site quality presence, ensuring components and finished medical devices meet all critical-to-quality requirements, specifications, and regulatory expectations. The position requires a highly self-directed individual capable of independently generating inspection documentation, developing inspection methods, and serving as a technical resource for supplier-related quality activities.
ESSENTIAL FUNCTIONS:
• Conduct on-site inspections at supplier facilities using appropriate gaging, metrology tools, and inspection methods to verify conformance to specifications.
• Develop, refine, and document inspection methods, including SOPs, work instructions, and inspection plans tailored to supplier processes and product characteristics.
• Independently generate inspection documentation, including inspection records, reports, and supplier feedback summaries (when applicable).
• Evaluate supplier-provided inspection data and verify accuracy, completeness, and alignment with Orthopediatrics' requirements.
• In partnership with development/design engineering, identify critical-to-quality characteristics and ensure inspection activities are aligned with risk-based quality expectations.
• Support CAPA activities related to supplier performance, inspection failures, or recurring quality issues.
• Assist with MSA and Gauge R&R studies to validate inspection methods and measurement systems used at supplier sites.
• Act as a subject matter expert for supplier-related inspection processes and daily quality operations.
• Maintain clean, safe, and organized inspection work areas while working independently at supplier facilities.
• Provide training or guidance to supplier personnel or new internal team members as needed.
• Support other operational quality activities when not performing supplier-site inspections
SUPERVISORY RESPONSIBILITIES: There are no supervisor responsibilities with this position.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
• Ability to work independently with minimal oversight in supplier environments.
• Strong ability to read and interpret product drawings/prints, specifications, and GD&T.
• Detailed knowledge of non-destructive testing, inspection techniques, and metrology equipment (micrometers, calipers, optical comparators, go/no-go gauges, etc.).
• Demonstrated experience developing and maintaining inspection-related SOPs and Work Instructions.
• Excellent verbal and written communication skills, including the ability to communicate effectively with suppliers, internal teams, and cross-functional stakeholders.
• Strong problem-solving skills and critical thinking abilities.
• Working knowledge of medical device quality system regulations, including FDA QMSR, ISO 13485, cGMP, cGDP, and EU MDR.
• Ability to maintain accurate documentation and records.
• Skilled in identifying and evaluating critical-to-quality attributes during inspection.
EDUCATION AND/OR EXPERIENCE:
• Minimum 4 years of product quality inspection experience in the medical device field.
• Experience performing inspections at supplier sites preferred.
• Knowledgeable in commonly used inspection methods, gauging, and measurement system validation.
• ASQ certification preferred.
• Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint).
LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and communicate effectively with suppliers, vendors, and internal employees. Requires excellent grammar and spelling.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
REASONING ABILITY: Ability to carry out instructions furnished in written, oral, or diagram form. Ability to use critical thinking to deal with problems involving multiple variables in a variety of situations.
CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver's license. Although employed by OrthoPediatrics Corp, this position will primarily work onsite at B&J Medical (4268 E US-6, Kendallville, IN 46755) to support day-to-day operations and business needs.
OTHER SKILLS AND ABILITIES: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.
PHYSICAL DEMANDS: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
WORK ENVIRONMENT: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Work is performed both in a normal office environment and in supplier facilities, where noise levels may vary from moderate to loud. Travel to supplier facilities is required. When not at supplier facilities, worksite location will be the Warsaw Distribution Center.
The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.