Supplier Quality Engineer

Millstone Medical; Fall River (MA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

Disability

Tuition Reimbursement

Career Pathing

401(k) with match

Job summary

Millstone Medical Outsourcing is seeking a Supplier Quality Engineer to support Tier 1 supplier projects and manage supplier quality programs. You will lead supplier assessments, audits, and CAPA-related activities to ensure compliance and quality across materials and processes.

Ideal candidates bring 5-7 years in ISO 13485 environments, strong problem-solving skills, and the ability to collaborate across teams.

Qualifications

• Experience in ISO 13485 environment is required.
• Experience with packaging materials and processing is highly desirable.
• Ability to work in a team environment.
• Able to multitask and work independently.
• Excellent problem solving and decision-making skills.

Responsibilities

• Perform supplier assessments including performance reviews, onsite audits, and quality agreement reviews.
• Lead supplier corrective action teams across multiple sites as part of the CAPA system.
• Lead change control efforts relating to supplier changes through the change control process.
• Manage supplier assessment schedule and PPAP/Plan development for Tier 1 suppliers.
• Monitor nonconforming materials and ensure timely disposition with internal/external teams.
• Provide internal and client-facing metrics and supplier performance reviews.
• Participate in internal and external audits as needed.

Skills

ISO 13485

CAPA

Root cause analysis

Supplier audits

Quality systems

Job description

Relocation assistance is not available for this position

Visa sponsorship is 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 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.

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

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

Summary:

The Supplier Quality Engineer is primarily responsible for supporting Tier 1 supplier projects at Millstone. The Supplier Quality Engineer will also:

• Perform supplier assessments including performance reviews, onsite audits, and quality agreement reviews.
• Lead supplier corrective action teams, sometimes across multiple sites, as part of Millstone’s CAPA system to investigate, determine root cause, develop and implement corrective actions.
• Lead change control efforts relating to supplier changes through Millstone’s change control process as necessary
• Manage supplier assessment schedule
• Develop and maintain Product/Process Specification plans and/or PPAPs for Tier 1 supplier programs
• Monitor open NONC (NCMR) records and work with internal and external team members to ensure timely disposition of affected materials
• Complete statistical analysis and provide metrics internally as well as to clients (supplier performance reviews) as required.
• Participate in internal and external audits as needed.

Qualifications:

• 5-7 years of demonstrated experience in an ISO 13485 environment
• Experience with packaging materials and processing is highly desired
• Ability to work in a team environment is essential
• Ability to multitask and complete work independently is crucial
• Excellent problem solving and decision-making skills are required

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.