Quality Engineer

Job Summary:
The Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits. Candidates must be located within commuting distance to the Wilmington, MA or willing to relocate to be considered.

• Contributes to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria, and statistical principles. Assists in writing and reviewing protocols, reports, and operating procedures to support product and process development.
• Supervises and performs risk management activities including creation and maintenance of risk management files by product and process as the key quality representative for those tasks.
• Support design control new product introduction teams as the quality subject matter expert and provide review and approval of product Design History Files.
• Act as the leader in bringing the culture of quality in medical device development.
• Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures.
• Collaborate with and guide cross-functional team members and stakeholders to ensure correct and efficient implementation of Design Controls and Quality System procedures.
• Active participant in assigned Design and Phase Review meetings.
• Drives improvements to the QMS including those resulting from quality events, audits, or regulatory changes to ensure compliance with FDA 21 CFR 820.
• Assisting in the development of the company quality system to support medical device offerings and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents as necessary, managing document change requests, and regularly reviewing procedures for appropriateness.
• Assisting with quality system implementation including, but not limited to:
  • Maintaining and documenting supplier approvals and audits as needed.
  • Participating in internal audits and serving as subject matter expert during regulatory inspections and notified body audits.
  • Assisting with and documenting regular management reviews.
  • Drafting and executing IQs, OQs, and PQs, where applicable.
  • Initiating, investigating, and reviewing non-conformances as well as corrective and preventative actions, as assigned.
  • Assisting in product failure and root cause investigations.
• Generally assuring adherence to all company quality procedures
• Other responsibilities as assigned.

Qualifications:

• Bachelor’s degree in mechanical engineering or biomedical engineering.
• Six Sigma Certification – Green, Brown or Black belt preferred.
• ASQ CQE preferred.

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.