Quality Assurance Engineer

Company

Capstone Development Services is a premier medical technology innovation and product development company that partners with leading global healthcare organizations to bring breakthrough technologies to life—faster. Our multidisciplinary team of engineers, clinicians, regulatory experts, quality professionals, and manufacturing specialists thrive on solving complex challenges with urgency and precision. From concept through design, verification, validation, regulatory strategy, and manufacturing transfer, we deliver validated, manufacturable medical technologies with the speed, agility, and technical excellence our partners depend on.

Overview:

Provide lead quality support for New Product Development Teams to ensure new/improved medical device products and processes are in compliance with applicable standards and regulations. Reports to the Director, Quality Assurance, Medical Devices.

Key Responsibilities

1. Assist with all elements of the design control system and DHF creation from a design quality perspective for new product development.
2. Execute within a QA system and team to ensure alignment with the Balmoral QMS while optimizing time to regulatory approval/clearance.
3. Coordinate with suppliers to review and drive the regulatory clearance and production readiness process which includes: engineering drawing review, gage development, capability studies, gage RRs, special process validations, tolerance stackups, CMM correlation studies, PFMEa, Process flows, control plans, inspection plans and DHR reviews. 
4. Develop and implement corrective/preventative action plans, internal CAPA’s and supplier SCARs.
5. Provide verification and validation, sampling, and statistical analysis support for all functions required for product clearance/approval through supplier relationships (e.g., mechanical testing, manufacturing special processes, packaging, sterilization)
6. Design and implement inspection methods, equipment, acceptance criteria and sampling plans to support qualified vendors
7. Ensure compliance to design control systems.
8. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines.

Qualifications (Skills/Education/Experience)

• Bachelor’s degree in engineering or an alternative Bachelor’s degree program
• 3 years experience in an Orthopedic Quality Engineering position
• Knowledge of design control requirements per ISO 13485 and 21 CFR part 820 and Quality system regulations and requirements (i.e. 21 CFR part 820, ISO 13485, ISO 9001, ISO 14971)
• Utilized problem solving using root cause methodologies (i.e. DMAIC, The Shainin System, Ishikawa)
• Knowledge of statistics, process control, and process capability
• Ability to apply statistics and software in data analysis (example Minitab)
• Understanding of application of Risk management ISO 14971 and failure modes and effects analysis (FMEA)
• Use of Computer Aided Drafting Software package (i.e. NX, Solidworks); Geometric Dimensioning and tolerancing (GD&T)
• Background in inspection methods and limitations based on engineering drawings and associated tolerances
• Ability to work within a team environment and build internal and external relationships (suppliers, regulatory agencies, etc.).
• Excellent communication skills – verbal and written
• The combination of education and experience may be considered relative to desired qualifications

NOTE:

·      Must be willing and able to travel~ 20%

·      Local candidates only and 4-day in-office requirement (Warsaw, Indiana).

·      Compensation: $85k to $100k base salary, competitive health benefits, 401k plan, and annual incentive opportunity

Send resumes and profile link to: Lisa Stohr (lstohr@capstonedevservices.com)