Type:

full-time

Job Description:

•Visa sponsorship not available for this position•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 device s.

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 complianc e. What's in it for y ou?

A company committed to quality, growth, career pathi ng.

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 famili es.

Total Rewards Benefits Progr am:

Medical, Dental & Vision - Starting on the 1st day of employ mentSupplemental Benefits - Life, Disability, Critical Ill nessPaid Time OffTuition Reimburse mentCareer Pat hing Millstone Medical Outsourcing is looking to hire a highly skilled and motivated Quality Engineer to join our team at Millstone Medical Outsour cing. Position S ummaryThe 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 satisfa ction.

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 investiga tions.

Job Specific Compet encies:

Me trology:

Perform dimensional inspections using a variety of metrology eq uipment.

Ensure accuracy and traceability of measurement systems.

Geometric Dimensioning & Tolerancing (GD &T):

Interpret and apply GD&T principles to product designs and inspection pr ocesses.

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 st andards.

Val idation:

Support validation activities for equipment, processes, and software (IQ, OQ, PQ) in compliance with regulatory requi rements.

Develop validation protocols and reports, ensuring that systems meet defined specifi cations.

T raining:

Develop and deliver training on quality standards, procedures, and best practices to the team and op erators.

Ensure training compliance for quality-related processes and systems.

Continuous Improvement P rojects:

Lead and participate in continuous improvement initiatives (Lean, Six Sigma) to enhance product quality and process eff iciency.

Identify opportunities to improve processes and reduce defects.

Complaint H andling:

Investigate customer complaints, perform root cause analysis, and implement corrective actions.

Communicate findings and resolutions to customers, ensuring transparency and building custome r trust.

Customer Liaison:

Serve as a point of contact for quality-related discussions with cu stomers.

Collaborate with customers to resolve quality issues and ensure their requirements are met.

Provide support during customer audits and quality asse ssments.

Regulatory Com pliance:

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 requi rements.

Procedure Writing and Docume ntation:

Develop, review, and update quality system procedures, work instructions, and inspection c riteria.

Ensure all documentation is aligned with industry regulations and best pr actices.

Knowledge & Skills:

3-5 years of experience in the medical device industry, with a focus on quality as surance.

Strong knowledge and understanding of metrology, CAPA, GD&T, experience interpreting engineering drawings and validation pr ocesses.

Six Sigma Green/Black Belt or ASQ Quality Engineer certification is a plus.

Proficient in the use of metrology equipment and s oftware.

Knowledge of quality management systems (QMS) and regulatory st andards.

Excellent problem-solving and analytical skills.

Superior written and strong communication skills for liaising with customers and cross-functiona l teams.

Ability to manage multiple projects and meet de adlines.

Minimum Educational Qualif ications:

Bachelor's degree in Eng ineering.

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

Additional In formation:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. 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