Job Title: Senior Quality Engineer

Job Description

We are seeking a highly skilled and experienced Senior Quality Engineer to ensure our product designs meet user needs and comply with regulatory standards. You will collaborate with various departments and lead quality planning activities for product and facility development. Your role will also involve risk management, quality issue resolution, and ensuring effective design control and transfer to production.

ResponsibilitiesConfer with external and internal departments such as Product Development, Clinical, Marketing, Sales, and Operations concerning product design to ensure user needs are met.Evaluate product design for manufacturability and suggest design process adjustments and quality improvements.Engage in the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing.Lead and participate in risk management activities.Lead quality issue resolution by applying root cause methodologies.Ensure effective design control and transfer to production.Lead quality planning activities for new product development projects, including verification and validation plans and reliability strategies.Lead quality planning activities in facility development, including verification and validation plans and reliability strategies.Essential SkillsMinimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology.Lean/Progressive Manufacturing and Quality disciplines.Supplier quality management.Audit management.CAPA (Corrective and Preventive Actions).Validation processes.Geometric Dimensioning and Tolerance (GD&T) experience.Additional Skills & QualificationsASQ Certified Quality Engineer (desirable but not required).Lead auditor certification (desirable but not required).Six Sigma Black Belt (desirable but not required).Accredited Lead/Biomedical Auditor certification preferred.Limit gauge design for dimensional verification.Problem-solving using root cause methodologies (i.e. DMAIC).Applying statistics and software in data analysis (example: Minitab).Application of failure modes and effects analysis (FMEA).Working with suppliers to design inspection systems and resolve quality issues.Quality system regulations and requirements (examples: 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 9001).Strong project management skills.Demonstrated knowledge of statistical sampling and analysis.Excellent organizational and writing skills.Proficiency with the MS Office Suite, including Microsoft Visio and Project.Fundamental understanding of design controls, project management, and basic manufacturing practices/processes.Work Environment

The position is based in a new 70,000 sq ft building. The dress code is business casual and includes a clean room environment. Standard working hours are from 8 AM to 5 PM, with a 40-hour work week and occasional on-call duties. The facility operates 24 hours a day, 5 days a week.

Pay and Benefits

The pay range for this position is $90000.00 - $110000.00/yr.

Friendly, open, and fun team culture that values unique perspectives, Company-wide dedication to profoundly impacting patients’ lives, Comprehensive, high-quality benefits package effective on date of hire , Educational assistance available for all employees , Matching 401(k) retirement plan, Paid holidays, including floating holidays, to be used at your discretion, Employee Stock Purchase Plan , Referral incentive program

Workplace Type

This is a fully onsite position in Vandalia,OH.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.