Job Description: Quality Assurance and Regulatory Compliance Manager
POSITION SUMMARY
The ideal candidate is a critical thinker who will proactively ensure compliance to and improve the quality systems of the Command Medical Products through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Incumbent ensures internal and external customer quality expectations are met; must have formal problem solving (Six Sigma, DMAIC, etc.) with MFG processes.
ESSENTIAL JOB RESPONSIBILITIES
• Internal Quality Issues
a. Disposition within 3 days for 90% of the issues
b. Identifies root causes and preventative actions within 30 days.
• Complaint Handling
a. Acknowledges within 24 hours and closes 95% of complaints within 30 days or less
b. Leads, directs, and ensures customer satisfaction in the resolution of quality failure events
c. Provides leadership analyzing customer returns
• CAPA’s
a. Closes 95% within 60 days
b. Leads/supports root cause identification of sustainable corrective actions for Corrective and Preventative Actions (CAPAs)
• Ensures inspection of all materials received to the proper levels within 3 days of receipt
• Drives continuous improvement by leading formal problem solving events with customers
• Utilizes SPC/Trending within incoming inspection and production to prevent potential issues within production.
• Plans and effectively executes internal audits to ensure compliance to the Quality System.
• Acts as Management Representative for all FDA, ISO and Customer audits with a goal of zero (0) major findings.
• Develops a strong team through coaching, mentoring, training and performance evaluations
a. Provides guidance and support to the Quality team, Engineers, Inspectors, Documentation Staff
• Explores, researches and recommends appropriate metrology equipment
• Assists and supports Customer visits
• Develops/expands processes improvements
• Manages and maintains all aspects of the quality system to ensure regulatory compliance, ISO Certification and product quality excellence.
• Performs other duties as necessary in support of business objectives.
EDUCATIONAL REQUIREMENTS:
· BA or BS in Engineering or technical discipline (will consider same/similar work experience in lieu of formal degree).
· GD&T Training preferred
TECHNICAL EXPERIENCE REQUIREMENTS:
· Experience with APQP, PFMEA, SPC, Metrology, Blueprints, and Control Plans
· QMS Administration, Supplier Quality Development
· Knowledge of:
a. Thorough understanding of FDA, ISO 13485;2016 Requirements and Auditing
b. Complaint Handling & CAPA Process
c. SPC/Trending
d. Documentation Control
INDUSTRY EXPERIENCE
· 5+ years relevant work experience in a MFG environment
· Demonstrated problem solving skills
· Demonstrated customer service skills
COMPETENCIES
· Must be resourceful – find ways to deal with barriers to success
· Must recognize own strengths and weaknesses
· Works through conflicts constructively
· Utilizes Fact Based Problem Solving
a. Analyzes and solves problems based on facts
b. Understands, practices & uses fact based problem solving tools (Fishbone, 8D, 5 Why’s, etc.)
· Analyzes Issues
a. Uses logical rational thought to make good decisions quickly
b. Gathers relevant information systematically
c. Considers a broad range of issues or factors
d. Grasps complexities and perceived relationships among problem or issues
e. Seeks input from others
f. Uses accurate logic in analysis
· Sets stretch goals for self and team
· Shows high level of accountability
· Provides praise and recognition along with constructive criticism and feedback
· Demonstrates ability to be respectfully assertive when necessary
· Highly organized with excellent attention to detail
· Must be a hands on person, willing to dig in as necessary
· Exhibits excellent Communication skills
a. Writes effectively; Conveys information clearly and effectively through formal and informal documents
b. Reviews and edits written work constructively
· Demonstrates ability with Process Evaluation/Improvement
» Analyzes current processes to determine if they need to be changed or if entirely new processes need to be implemented
» Identifies opportunities to improve a process by making it more efficient and/or effective while achieving superior results
· Utilizes Workflow Analysis
» Decomposes high level functions into their functional pieces and analyzes the processes to determine how efficiently the functions are being performed.
· Utilizes Statistical Tools
» Has high level of understanding and use of SPC, regression analysis, significance testing, measurement system analysis, as quality improvement tools
· Applies Error Proofing
» Understands the use and design of error proofing devices
· Metrology Tools
» Understands the use and maintenance of calipers, height gages, gage blocks, etc.
Command Medical Products operating systems principles and objectives
· Recognizes and discerns all CMP established operating systems (e.g. quality, environmental)
· Understand the responsibility to maintain; familiarity, the systems and this position’s role in support of these systems, including a consideration of the impact of individual actions on the systems and the responsibility to communicate concerns and improvement ideas
CULTURAL EXPECTATIONS
All that we do is inspired and guided by our Core Values. These principles impact how the business is managed from day to day decisions through leadership deployment of long-term strategic planning. The entire employee family within Command Medical Products hare a common belief in our core values and we are proud of what they stand for.
· Accountable to our; Employees (well-being), Customers (value), Stakeholders (profitability), Community (stewardship)
· Lead and act with Integrity, Honesty and Respect
» Personally earn the trust of colleagues, customers, suppliers, partners, stakeholders and our community in every interaction
o Begin with trust, expecting people to act in good faith
o Be open, fair and honest
o Honor commitments and be accountable to each other, adult-to-adult
» Have a bias toward action and look at every experience as a learning opportunity
o Be curious and continuously learn and grow
o Seek out new challenges and take calculated risks
o Lead by example and provide opportunities for other to learn
» Be a team player; place our shared fate above personal ambition
o Embrace a diversity of thinking and respect each person’s unique contribution
o Create an environment free of fear, where healthy conflict leads to better solutions
o Be open to the unknown and the possibility of being uncomfortable
o Recognize others’ contributions to the team’s success
» Steward our Legacy; Preserve the legacy of our founders while reinventing the business for the next generation
o Celebrate our shared heritage
o Make a difference by creating something better than what you begin with
o Invest in businesses, people, and communities for the long term
o Take personal responsibility for heal, safety and our environment