Description
Position: QARA Quality Systems Senior Engineer / ManagerCompany: Medical Device
Location: Indiana
JOB SUMMARY:
The QARA Quality Systems Senior Engineer / Manager is responsible for writing and editing companywide process flowcharts and system documentation that is intuitive and effective in order to achieve and maintain a state of business excellence. The Q ARA Quality Systems Senior Engineer / Manager participates in setting the corporate direction for Quality System documentation, ensuring the effective deployment and execution of the various Quality System processes, and drives the corporate documentation to achieve integrity, consistency, and regulatory compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned):
- Lead process mapping exercises for applicable processes
- Collaborate with process owners and department personnel to change, improve, and create flowcharts and process documentation such as forms and standard operating procedures based on intuitive design and Good Documentation Practices (GDP). This includes understanding procedures, gathering information, analyzing procedures, addressing issues, resolving problems, and implementing change
- Consolidate documentation content to minimize/eliminate redundant information
- Work with global entity personnel to ensure process documentation is consistent from location to location
- Work independently
- Take concepts & high level direction in order to successfully translate content into appropriate documentation
- Develop intuitive, coherent, easy to follow documentation that aligns with regulatory requirements
- Participate in brainstorming sessions to identify root causes of gaps/observations and corrective actions
- Recommend and implement improvements to the quality system processes driven by new regulations, industry standards, new technologies, internal business needs
- Ensure adequate training is conducted and competency is maintained among key process stakeholders
- Participate in external and internal regulatory inspections
- 2+ direct reports
- Strong influencing, negotiations and leading without direct line authority experience
QUALIFICATIONS:
- Excellent communication skills, attention to detail; questioning/listening skills; ability to look beyond obvious answers to understand the impact on other areas
- Thorough working knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive, ISO Quality System and other applicable industry requirements
- Proven ability to prioritize and manage multiple projects and meet deadlines
- Excellent organizational skills and ability to plan and implement resolutions to problems
- Ability to communicate between various organizations and work with multifunctional teams
- Ability to make effective presentations to all levels of the organization
- Strong appreciation of the impact of regulatory bodies on medical device product lifecycle
- Experience working with diverse cultures and employees
- < 5% travel
REQUIREMENTS:
- Bachelors Degree in science discipline
- 5+ years in the medical device industry or related GMP environment
- 5+ years experience with documentation / technical writing skills in a regulated compliance environment
- 3+ years experience with cGMP quality system regulations & investigations
- 3+ years experience working with/leading crossfunctional teams
- Strong proficiency in Agile, MS Word, Visio, Excel, PPT, Project
- ASQ
- Prior experience with doc control, CAPA, auditing
- Six Sigma Process Excellence tools, training, certifications
To find out more about Real Staffing please visit www.realstaffing.com