Job Description

Whip Mix is a manufacturer of dental supplies and equipment, selling globally. Please review our website at www.whipmix.com

The Quality Engineer is responsible for all aspects of quality assurance in the design, production and technical documentation of medical device products.  Is responsible to develop and implement tests that monitor the quality of the medical device in each stage of the production process.   Ensures medical device documentation is maintained in accordance with cGMP, ISO 13485, MDR and MDSAP.

 

This position supports product development teams to ensure compliance of new or modified products and processes to the appropriate quality standards.  Assist in preparing 510(k) notifications, and technical files required for device registration.  

Initiates, cooperates or participates fully as appropriate in using the team approach in solving problems and suggesting improvements that enables Whip Mix to live up to its mission and values.  Whip Mix Corporation is an EEO employer.

 

1. Works with design team to ensure Design & Development activities produce a product that is safe and meets customer needs.  Helps develop D&D documentation in accordance with applicable ISO and regulatory standards.  | 20%
2. Helps design and validate production process for the manufacture of medical and non-medical products and monitors process performance.  | 15%
3. Coordinates for creating 510(k) and CE Mark documentation.  | 10%
4. Ensures and maintains the device technical documentation is in compliance with ISO and regulatory standards.  | 10%
5. Coordinates external quality system audits conducted by outside parties such as FDA, ISO, customer inspectors/auditors. | 10%
6. Conducts risk and capability analysis to evaluate and validate product design and process capability and ensures design master/history files contain appropriate information. | 10%
7. Participate on new product development teams to ensure the appropriate regulatory requirements are met for new/improved products. | 10%
8. Helps develop the quality plan for incoming and outsourced materials and products. | 5%
9. Assists the quality team to conduct root cause analysis, corrective action planning, follow-up on actions and timely closure of CAPS’s. | 5%  
10. Conducts data analysis and creates trend charts using statistical methods. |5%
11. Performs other functions or duties as assigned.   

Knowledge, Skills, Abilities, & Worker Characteristics

1. Proficiency in Microsoft Office required.  
2. Ability to effectively interpret, communicate and assimilate regulatory standards and specifications.
3. Requires an in-depth knowledge to develop a statistically valid protocol to validate product design and process capability
4. Knowledge of quality tools such as FMEA and root cause analysis is required 
5. In-depth knowledge of relevant regulations such as FDA, ISO 13485, and ISO 14971, and the ability to apply these regulations to product development and manufacturing.

·         Bachelor’s Degree in Engineering or related field.

·         Advanced training related to QMS disciplines.

·         Auditor and QE certifications are preferred.

·         At least (5) five years of experience managing/developing a QMS that meets FDA and ISO 13485 requirements preferred.

·         Experience in process validation, CAPA activities and production non-conformances required.
·         An equivalent combination of education, training and experience may be substituted.

Primarily office environment, however, must be able to access and audit all work areas within the manufacturing plant.

Must be able to spend a full day touring the plant during audits and customer visits.

Must be able to communicate effectively with manufacturing and office team members.

 

Salary Range:  $80,000 - $90,000

Full benefits package of vacation, medical, vision, company paid dental insurance, life insurance, short- term and long-term disability.