Day to Day — We are seeking a Quality Engineer to join a top medical device company in Alpharetta, GA. This role will be support a team responsible/leading charge of a brand new manufacturing facility being built in Johns Creek, GA that is absorbing some product lines and supporting a recent product acquisition and efforts to consolidate a 3rd party manufacture and bring capabilities in-house. The Quality Engineer II is responsible for providing Quality Engineering input to support Manufacturing, Manufacturing Engineering, Operations and Distribution activities. Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet company, customer, and regulatory requirements. This individual will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. The Quality Engineer II leverages extensive technical quality knowledge and experience across multiple product and production platforms with a high degree of independence.
responsibilities include:
* Supporting specific production areas in achieving required quality standards; provide guidance to quality inspectors and technicians as needed
* Leading and supporting cross-functional teams in identifying root causes and implementing corrective and preventative actions (CAPA) to control and reduce manufacturing process defects (scrap, nonconforming material, customer complaints); may be responsible for creating risk analyses and FMEAs
* Initiating and leading nonconforming events and CAPA projects; support internal and external regulatory audits
* Collecting and analyzing process defect data to support product and process improvement efforts; apply problem-solving methodologies to identify, prioritize, communicate and resolve quality issues
* Gathering and analyzing quality metric data to enhance sustaining product design and new product development; support site and divisional projects to ensure product introductions, processes and related changes meet regulatory requirements
* Assessing design and process changes to determine the impact on patient care and compliance to quality system requirements; own risk management documentation for assigned processes
* Leading continuous improvement projects and identifying best practices
Required Skills & Experience
Must Haves —
* 3+ years of medical device engineering experience
* Bachelors degree in engineering
* Quality Standard documentation creation (SOPs, Non-conformances, Root-cause investigations, CAPAs, FMEAs, DFMEAs…etc)
* Experience supporting internal and external regulatory audits
* Proven ability to work cross-functionally with other departments and engineering teams
Nice to Have Skills & Experience
Plusses —
* Six Sigma Certification
* ASQ CQE/CBA Certification
* Knowledge of analytical techniques and statistical analysis
* Experience with Manual to Automated processes