Job Description
Day to Day -- We are seeking a Sr. Quality Engineer to join a top medical device company in Alpharetta, GA. This role will be supporting 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 Sr. Quality Engineer 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
responsibilities include:
* Provides leadership role on championing departmental or cross-functional engineering initiatives.
* Provides project direction, coaching, and mentoring for engineering and technical team personnel.
* Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
* Mentor for technical guidance for identifying and resolving quality issues.
* Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
* Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
* Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
* Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
* Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Required Skills & Experience
Must Haves --
* Bachelor's degree in Biomedical Engineering or related engineering discipline
* 5+ years of technical experience in the medical device or pharmaceutical industry
* Validation experience
* Knowledge of risk management concepts, proven track record of developing, implementing and execution
* Internal/External audit experience
* Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485 with ability to understand other medical device regulations and standards
* Experience with nonconforming material, CAPA methodologies and related systems
* Experience working in cross-functional teams and driving projects to completion
Nice to Have Skills & Experience
Plusses --
* Certified Six Sigma Green Belt (CSSGB)
* ASQ Certified Quality Engineer (CQE) or Biomedical Auditor (CBA)
* Project management experience with strong presentation and facilitation skills
* Working knowledge of analytical techniques and statistical analysis
* Proficient with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent)
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.