Senior Design Quality Engineer
About The Position
This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities. We are seeking a Senior Design Quality Engineer to join our MS&T team. In this role, you will provide quality engineering leadership and expertise to technical development programs, new business programs, and customer-facing product development activities. This role partners closely with cross-functional teams and customers to ensure quality is embedded throughout the product development lifecycle through the application of Quality by Design (QbD) principles and Design of Experiments (DOE). You will support the identification of quality, regulatory, and validation requirements early in development to facilitate robust product and process design while effectively meeting customer and business objectives.
Requirements
- BS in Engineering or Life Sciences
- 5-8 years of quality assurance or quality engineering experience in the medical device or pharmaceutical industry
- Quality engineering support experience for process improvement or process development.
- Experience in process/equipment validation.
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.
- In depth understanding of common process development and engineering development activities and proficient in experimental statistical and design of experiments.
- In depth understanding of design control and regulatory requirements for process design and transfer.
- In depth understanding of current good manufacturing practices (cGMP) and typical regulatory concerns affecting medical device and/or drug manufacturing.
Responsibilities
- Maintain knowledge of best industry practices to provide quality oversight and related initiatives for process development.
- Ensure validation strategies for clinical and commercial products are developed and executed in compliance with regulatory requirements, supporting robust processes and consistent product quality.
- Ensure development programs comply with the Quality System and all Design Control requirements.
- Use quality engineering concepts to monitor, support and critically review process development efforts.
- Review and approve experimental plans, development processes, equipment/process qualification and controlled documentation.
- Mentor good experimental technique and statistical/technical data analysis.
- Ensure data is reviewed and trends are investigated in a manner that ensures robust process quality.
- Provide guidance in structure of product development process documentation.
Benefits
- Opportunities to learn and grow with a well-respected company
- Competitive compensation with annual reviews and a company-wide incentive bonus
- 3 medical insurance plans to fit your needs and budget including an HSA Plan with company contributions.
- Low cost dental and vision insurance
- Short term disability, long term disability and life insurance all 100% company paid
- 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!)
- 9 paid company holidays plus 2 personal holidays
- Paid family leave
- Tuition reimbursement
- 401k plan with company matching contribution
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What This Job Offers
Job Type
Full-time
Career Level
Senior
