Quality Engineer

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

• Medical, Dental & Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing

Millstone Medical Outsourcing is looking to hire a highly skilled and motivated Quality Engineer to join our team at Millstone Medical Outsourcing.

Position Summary

The Quality Engineer will be responsible for ensuring the highest quality standards in a fast-paced work environment. The role focuses on metrology, GD&T, CAPA, validation, and continuous improvement initiatives. Additionally, the position will involve procedure writing, training, customer liaison, and complaint handling to ensure regulatory compliance and customer satisfaction.

This position will assist in performing the essential duties and responsibilities listed below ensuring that customer and internal requirements are met while meeting the requirements of the company’s Quality Policy, established Quality Objectives, as well as regulatory requirements as outlined in ISO13485, FDA 21 CFR Part 820 & 1271.

The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects to strict deadlines. Specific functional areas include the creation and maintenance of system procedures & work instructions, support the internal auditing program, as well as data analysis, complaint handling, and CAPA investigations.

 

Job Specific Competencies:

Metrology:

• Perform dimensional inspections using a variety of metrology equipment.
• Ensure accuracy and traceability of measurement systems.

Geometric Dimensioning & Tolerancing (GD&T):

• Interpret and apply GD&T principles to product designs and inspection processes.

Corrective and Preventive Action (CAPA):

• Lead the investigation of quality issues, root cause analysis, and implementation of corrective and preventive actions.
• Monitor and document CAPA activities to ensure timely closure and compliance with regulatory standards.

Validation:

• Support validation activities for equipment, processes, and software (IQ, OQ, PQ) in compliance with regulatory requirements.
• Develop validation protocols and reports, ensuring that systems meet defined specifications.

Training:

• Develop and deliver training on quality standards, procedures, and best practices to the team and operators.
• Ensure training compliance for quality-related processes and systems.

Continuous Improvement Projects:

• Lead and participate in continuous improvement initiatives (Lean, Six Sigma) to enhance product quality and process efficiency.
• Identify opportunities to improve processes and reduce defects.
• Complaint Handling:
• Investigate customer complaints, perform root cause analysis, and implement corrective actions.
• Communicate findings and resolutions to customers, ensuring transparency and building customer trust.

Customer Liaison:

• Serve as a point of contact for quality-related discussions with customers.
• Collaborate with customers to resolve quality issues and ensure their requirements are met.
• Provide support during customer audits and quality assessments.

Regulatory Compliance:

• Ensure compliance with relevant regulatory standards, such as ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Maintain accurate and thorough documentation to meet regulatory and customer requirements.

Procedure Writing and Documentation:

• Develop, review, and update quality system procedures, work instructions, and inspection criteria.
• Ensure all documentation is aligned with industry regulations and best practices.

Knowledge & Skills:

• 3-5 years of experience in the medical device industry, with a focus on quality assurance.
• Strong knowledge and understanding of metrology, CAPA, GD&T, experience interpreting engineering drawings and validation processes.
• Six Sigma Green/Black Belt or ASQ Quality Engineer certification is a plus.
• Proficient in the use of metrology equipment and software.
• Knowledge of quality management systems (QMS) and regulatory standards.
• Excellent problem-solving and analytical skills.
• Superior written and strong communication skills for liaising with customers and cross-functional teams.
• Ability to manage multiple projects and meet deadlines.

Minimum Educational Qualifications: Bachelor’s degree in Engineering, Quality Assurance, or a related field.

To learn more about Millstone Medical, please visit us online at www.millstonemedical.com.

Additional Information:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.