Website Mack_Molding Mack Molding Co.
Are you interested in helping improve the lives of patients around the world, working with some of the top fortune 500 companies to launch their new products, or start-up companies with new cutting edge technology? If the answer is yes, Mack would like to talk to you about joining our team as a Quality Engineer in our Medical Products group.
As the manufacturing arm for our customers, Mack has built a worldwide reputation as a reliable provider of plastic injection molding and contract manufacturing services. In many ways, our quality team holds our license to play in the field, ensuring our work not only meets the high demands of our customers, but also the patients who rely on them. As a quality engineer you will support our growing operations from new business development through product launches and realization all the way through program end of life. You will be part of a team, working with the program manager and other functional areas such as purchasing and manufacturing engineering to ensure we achieve Mack’s mission of Total Customer Satisfaction.
Primary Responsibilities
- Provide Quality Engineering support for the manufacturing of electromechanical products, including IVD and Class III medical devices
- Monitor, evaluate and report on process trends, and provide summary reports to Customers
- Lead quality related problem solving and root cause analysis to resolve manufacturing issues
- Respond to customer complaints and evaluate customer returns, utilizing 8D problem solving methodology
- Develop and maintain Quality Plans and Process Control Plans
- Ensure proper change control procedures are adhered to
- Lead process validation activities for new or revised products (OQ/PQ), including generating Manufacturing Process Validation Protocols and Completion reports
- Provide leadership and guidance to ensure compliance to quality system regulations, including FDA 21CFR Part 820, ISO 13485 and IVDR
- Participate in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes
Qualifications
- Bachelor’s degree in a technical field (science, engineering, biomedical or similar) and at least two years of experience in the medical device industry preferred. Minimum education requirements are a H.S. diploma with 3 or more years of related quality experience or a Bachelor’s degree in a technical field (science, engineering, biomedical or similar) with 0-1 year of related experience.
- Experience with quality system regulations 21CFR Part 820, ISO 13485, and IVDR
- Experience conducting manufacturing/process validations (OQ/PQ)
- Working knowledge of statistical techniques, including sampling plans, SPC, process capability, Gage R&R
- Strong analytical and problem solving skills
- ASQ Certified Quality Engineer preferred
Employees are one of the Company’s most valuable assets, and Mack is committed to honoring their contributions through competitive compensation packages, diverse career paths, advancement opportunities and by nurturing a team-oriented, engaging work environment. This position is located in beautiful Vermont with an unparalleled quality of life.
If interested, please complete Mack’s on-line application form (see link below) or send hard copies of your resume, compensation expectations and a letter of introduction to:
Mack Molding Company
608 Warm Brook Road
Arlington, VT 05250
Attn: Human Resources
802-375-0792 (fax)
Resumes accepted from qualified applicants only.
Equal opportunity employer.
