Website Mack Prototype
Mack Prototype is the premiere source of a wide range of rapid prototyping services designed to enhance customers’ product development cycle. With a range of expertise including rapid prototyping FDM, CNC machining, polyurethane molding, and low-volume injection molding, Mack Proto is uniquely positioned to produce exceptional products. To help maintain our high quality standards, the Company is looking for a quality inspector to ensure we reach the high standards our customers expect.
Plans, coordinates and directs quality assurance program designed to ensure quality production of products consistent with established standards. Determines and documents monitoring and measurement activities and equipment needed to provide evidence of conformity to parts and products.
- Formulate and maintains quality assurance objectives complementary to corporate policies and goals.
- Interpret quality assurance philosophy to key personnel in organization.
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
- Determine and conduct the measurement to be undertaken to ensure product and parts conform to customer or regulatory requirements
- Ensure all equipment utilized for metrology activities is maintained and calibrated in accordance with ISO and Industry requirements
- Lead projects that improve quality systems; example includes creating procedures for reporting, analysis, and resolution of material non-conformance indices.
- Review all data obtained during all quality assurance activities to ensure consistency with company and customer policies and procedures.
- Lead quality root cause analysis that results in timely resolution of audit findings, product complaints and/or safety issues.
- Prepare and present technical and program information to the management team.
- Maintain a working knowledge of relevant government and industry quality assurance codes and standards.
- Assist with FAI, startups, and final inspection during peak periods as required.
- Responsible for any ISO Procedures as called out in the Quality Manual
- Assist in verification and validation projects
- Other duties may be assigned.
- High School Degree or equivalent
- 5-10 years related experience and/or training in medical device industry is preferred
- Proficient with standard dimensional gages-caliper, micrometer, drop indicator, comparator
- Proficient with Coordinate Measuring Machine (CMM), Vision Systems, Digital Optical
Comparator, and other advanced measurement/test equipment (preferred)
- Ability to read and interpret 2D prints and customer requirements
- Familiar with ISO (13485 preferred)
- Highly organized and detail oriented
- Working knowledge of U.S. and international regulations expected
- Working knowledge of desktop computer office software and e-mail is required
- Excellent verbal and written communication skills
- Flexibility to handle multiple tasks at once and meet timelines
- Recognized by others as having expertise in areas of the quality system SOPs, industry standards, and/or governmental regulations
Employees are one of the Company’s most valuable assets, and Mack Proto is committed to honoring their contributions through competitive compensation packages, diverse career paths, advancement opportunities and by nurturing a team-oriented, engaging work environment.
If interested, please complete the on-line application form (see link below) or send hard copies of your resume, compensation expectations and a letter of introduction to:
Attn: Human Resources
424 Main Street
Gardner, MA 01440
Resumes accepted from qualified applicants only.
Equal Opportunity Employer