SUPPLIER QUALITY ENGINEER
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Millstone Medical Outsourcing is seeking an experienced and highly motivated individual to join its Quality Team as a Supplier Quality Engineer. Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry.

Come join Millstone and become part of our dynamic organization!

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.

• *JOB SUMMARY: The Supplier Quality Engineer is primarily responsible for supporting Tier 1 supplier projects at Millstone Medical.

RESPONSIBILITIES:

• 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. Travel is required for external supplier audits. travel time would be 20%.
• All other duties as assigned

KNOWLEDGE & SKILLS REQUIRED:

• Bachelor’s degree required
• 3-5 years relevant Quality experience. ISO 13485 and FDA environment experience highly preferred, although experience from other highly regulated industries or ISO 9001 industries may be considered.
• Must possess excellent verbal and written communication skills, English is required
• Customer service & interpersonal skills must be superior
• A keen eye for detail is critical
• 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 vital

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ADDITIONAL INFORMATION:*
Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay and voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing’s opportunities, please visit us online at www.millstonemedical.com.
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.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

Job Type: Full-time

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Application Question(s):

• Do you have experience working directly with the supplier?

Work Location: In person

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