| Location: | Lowell Inc. |
|---|---|
| Job Type: | Full Time |
| Reports to: | Director of Engineering |
Position Summary (Main Purpose)
Lowell Inc. is seeking a Validation Quality Engineer with a strong emphasis on validation (IQ/OQ/PQ). In this role, you will support validation activities for both new product introductions and internal equipment/processes requiring validation or revalidation, while also contributing to broader quality engineering responsibilities. You will ensure compliance with ISO 13485:2016, FDA 21 CFR Part 820, and other applicable standards to support the manufacture of implantable medical devices.
Lowell is the premier partner for the development and production of technologically advanced, implantable medical devices for the cardiovascular, spine, trauma and extremities markets. We manufacture components and assemblies that save lives and improve quality of life.
Primary Responsibilities
- Lead and support validation activities for processes, equipment, and new product introductions (IQ, OQ, PQ).
- Develop, execute, and document validation protocols and reports, ensuring statistical validity and regulatory compliance.
- Maintain and update the Validation Master Plan (VMP) to ensure processes and equipment remain in a validated state.
- Collaborate with cross-functional teams (engineering, operations, project management) to define and meet validation requirements.
- Perform process capability and statistical analysis (e.g., DOE, SPC, Cpk) as part of validation activities.
- Conduct validation gap assessments and plan revalidation activities when process or equipment changes occur.
- Support quality engineering functions including:
- Internal and external audits
- CAPA investigation and follow-up
- Risk management activities in alignment with ISO 14971
- Training and guidance on validation and quality best practices
- Assist in continuously improving the quality management system (QMS) and quality culture across the organization.
Preferred Qualifications:
- Hands-on experience with IQ/OQ/PQ validation in a regulated environment
- ISO 13485:2016 knowledge; auditing experience a plus
- ASQ-Certified Quality Engineer or related certification (preferred)
Education/Experience:
- Bachelor’s degree in Engineering, Quality, or related technical field
- 3+ years of quality engineering experience in medical device or other regulated industry, with direct validation experience
Knowledge, Skills, Abilities:
- Strong understanding of validation requirements (process, equipment, software) under ISO 13485 and FDA regulations
- Proficient in statistical analysis and related software (Minitab or equivalent)
- Excellent documentation and organizational skills with attention to regulatory detail
- Ability to manage multiple validation projects concurrently
- Proficient in Microsoft Office Suite, with advanced Excel skills
- Strong interpersonal and communication skills for cross-functional collaboration
- High integrity and commitment to compliance in a regulated environment
Benefits
- Lowell offers a competitive compensation and benefits package including Medical, Dental, Vision, Life Insurance, Short Term Disability, 401k Retirement Plan with 3% employer contribution, and Profit-Sharing plan.
If you are a highly motivated individual who takes pride in their work, we would love to hear from you. Please submit your resume to Shelly.anderson@lowellinc.com
This description covers the primary purpose and principal duties of the job. It is not designed to be a complete list of all the duties and responsibilities required of this position. Duties, responsibilities, and activities may change at any time with or without notice.
