Position: Quality Engineer

Location: Franklin, Indiana

Overview: Quality Engineers work to ensure the overall quality of manufactured products. They test processes, monitor quality standards, create documentation, devise quality tests and define the criteria a test result should meet. Quality Engineers monitor the quality of a process and play a key role in fixing issues when they arise.

Requirements

• Maintain and monitor the inspection and testing of materials, parts, and products to ensure adherence to established quality standards.
  Oversee Quality Associates on production floor.
• Provide manufacturing support through training, and guidance of Receiving Inspectors, Final and In-Process Inspectors to ensure compliance with product specifications, Food and Drug Administration’s GMPs and ISO.
• Ensure that training is performed and documented. Maintain the training matrix that is used to create and update job descriptions.
• Develop and train QC personnel in inspection protocols/techniques and equipment usage.
• Develop specifications of materials, parts, and products based upon inspection results.
• Maintain Nonconforming Review and related corrective actions.
• Provide direction to QC staff regarding the facilitation of nonconforming material, material review boards (MRB), containment and disposition of nonconforming review.
• Confirm all equipment is identified and maintenance/calibration remains current. Completes and maintains all QMS forms are completed and on file.
• Ensure timely scheduling of raw material inspection, product inspection, auditing, and data collection.
• Work with Operation personnel to develop control plans such as inspection plans, first articles, and process validation.
• Maintains complete and current archives of all quality records.
• Initiates and maintains new change orders, ensuring the appropriate approval and training requirements are documented and executed.
• Ensure that all change order implementation activities are completed and appropriately documented.
• Meet production schedule to max efficiency and timeliness, within assigned budget.
• Establish applicable statistical methods within the Quality Control acceptance activities such as process capability and sampling.
• Provide support on audits (internal and external) of the quality management system and processes.
• Responsible for risk management and Corrective and Preventative Actions.
• Reviews and maintains client, customer, and user feedback.

Candidates Must Have

• Bachelor’s degree in engineering, or related field. Equivalent professional experience will be considered.
• Effective communications skills, including writing, speaking and active listening. Needs basic experience within Microsoft Office, Word, and Excel.
• Three to five years of Quality experience in regulated manufacturing facility (ISO, IATF, Etc.)
• Preferred familiarity of ISO standards. (ISO 13485 or ISO 9001)

Compensation

The base salary for this position is commensurate with experience and qualifications.

Rocky Mountain Orthodontics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

This job description outlines the role, responsibilities, qualifications, and compensation for the Manufacturing Manager position at Rocky Mountain Orthodontics. If you have any specific requirements or need additional details, please let us know!

About Us

Rocky Mountain Orthodontics (RMO) is the oldest privately held orthodontic manufacturing and supply company in the industry, serving orthodontists and dental professionals for over 89 years. RMO recently relocated its global headquarters to Franklin, Indiana, and employs over 80 employees in the USA. We manufacture and distribute over 25,000 unique products to the dental profession under ISO 13485 MDSAP and European MDR standards, serving customers in over 90 countries globally. Our subsidiary, RMO Europe, located in Strasbourg, France, supports the European orthodontic market with 40 employees.