Sr. Quality Engineer

Tecomet; Wilmington (MA); On-site; USD 100,000 - 135,000; Full time

Job summary

Tecomet in Massachusetts is seeking a Sr. Quality Engineer to drive quality systems, process control and regulatory compliance across manufacturing operations.

You will maintain FDA/ISO compliant programs, support MRB, CAPA, PPAP, and lead quality improvements with Six Sigma tools while interfacing with internal and external customers to meet quality, cost and schedule targets. Ideal candidates have experience in medical device manufacturing and ASQ CQE; strong problem solving, GD&T, and

Qualifications

• Bachelor's degree required or equivalent in quality or related field.
• ASQ CQE or CMQ/QE preferred.
• 4 years’ quality experience in medical device manufacturing preferred.
• ISO 13485, FDA 820 familiarity preferred.

Responsibilities

• Maintain quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/operations to resolve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, PPAPs.
• Coordinate process validations and reduce inspection reliance.
• Generate quality metrics and cost of quality reports.
• Investigate customer complaints and implement CAPA and corrective actions.
• Write and maintain quality-related procedures.

Skills

Manufacturing operations

Quality Systems

FDA GMP ISO

GD&T

Problem solving

8D

MS Office

Education

Bachelor’s degree in quality

Job description

Position Type

Full-time

Travel Requirements

N/A

Job Description

Sr. Quality Engineer

Position Summary

The Sr. Quality Engineer will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet’s principles of continuous improvement, customer driven innovation and a win-first culture, while meeting company financial and other performance metrics.

• Maintaining applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Supporting the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
• Special projects assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.
• Writing and maintaining quality related work instructions and procedures.

Qualification Requirements

Credentials/Experience:

• Bachelor’s degree in quality or related field and/or a combination of education, certifications and experience will be considered

Experience/Educational/Training Preferred:

• ASQ CQE or CMQ/QE preferred
• 4 years’ experience in quality within medical device manufacturing industry preferred
• ISO 13485, FDA 820 and customer interaction experience preferred

Knowledge, Skills, and Abilities:

• Manufacturing operations – forging and/or machining.
• Quality Systems.
• Regulations – FDA, GMP and ISO.
• GD&T.
• Problem solving and 8D.
• Microsoft office (Word, Excel, Outlook, PowerPoint).

Other Requirements

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%

Pay Range

$100,000.00 - $135,000.00 / year

Pay Transparency

In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.

Tecomet is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, age, genetic information, national origin, or protected veteran status and will not be discriminated against on the basis of disability.