Duties and Responsibilities:
- Responsible for participation in new product development activities as the Quality engineering lead to ensure that all validations are accurately completed.
- Lead and coordinate all quality engineering deliverables and activities to ensure completion in accordance with project timelines
- Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ) for a Class I medical device manufacturing facility with a main focus on molded parts.
- Collaborate with project team on machining, molding, packaging and cleanroom activities related to new launch products
- Review and approve documents through Change Order process.
- Responsible for collaborating with Quality, product development and manufacturing to develop inspection plans for devices being developed
- Responsible for Investigating and troubleshooting product complaints or production issues.
- Responsible for ensuring that workflows, processes, and products comply with regulations
- Collaborate with project team to develop inspecting and testing methods, equipment, processes, and criteria to ensure quality specifications are met.
- Ensure validation efforts are conducted in an appropriate and timely manner; follow up with applicable departments independently.
- Support risk assessment exercises related to validation and product development activities.
- Identify deviations from established product or process standards and provide recommendations for resolving deviations.
Qualifications:
- Requires a Bachelor's degree in Engineering
- At least Five years’ work experience in a regulated industry (medical device preferred)
- Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971
- Experience working with new product launch teams
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Excellent computer proficiency (MS Office – Word, Excel and Outlook)
- Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
- Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
- Experience with molding and machining process validation and molded parts is preferred
- Experience with cleanroom and packaging activities is preferred
Work Environment: While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Application Question(s):
Do you have experience working with new product development and launches?
- Do you have experience performing statistical analysis to make decisions?
- Do you have experience with component and equipment validations using IQ/OQ/PQ?
- Do you have experience leading projects and quality engineering initiatives?
Experience:
- New product development: 1 year (Required)
Work Location: In person
