Quality and Regulatory Compliance Manager

JOB TITLE: QUALITY ASSURANCE & REGULATORY COMPLIANCE MANAGER

POSITION SUMMARY

The ideal candidate is a critical thinker who will proactively ensure compliance to and improve the quality system of Command Medical Products through internal audits, participation in process improvement programs and interaction with key stakeholders.  The incumbent must insure internal and external customer quality expectations are met. Formal problem solving experience in manufacturing environment using tools such as Six Sigma/DMAIC is a requirement.

ESSENTIAL JOB RESPONSIBILITIES

  • Lead the quality department as part of the executive team to collaborate on company strategy and deployment with direct accountability for quality department budget.
  • Manages and maintain all aspects of the quality management system to ensure regulatory compliance, maintenance of ISO certification and product quality excellence
  • Acts as management representative for all FDA, ISO and customer audits with a goal of zero (0) major findings
  • Develop and supervise highly functional quality department including: Quality lab supervisor, documentation control clerk(s) and quality engineers. Provide guidance, support, coaching, mentoring, training and ongoing performance feedback to foster a strong and collaborative team
  • Create and maintain internal audit plan inclusive of: auditor training, scheduled plan for audit completion and closure of internal audit findings to ensure compliance to the quality management system
  • Provide specific oversight of incoming area to ensure raw materials are received into inventory via appropriate inspection within designated time frame metric to support production requirements. Current target of 3 days from receipt
  • Implement companywide utilization of SPC/Trending within incoming inspection and production to prevent potential issues and support continuous improvement objectives
  • Assume ownership for tactical execution of the quality department with specific emphasis on meeting metrics established including:
    • Internal Quality Issues
      1. Disposition within 3 days for 90% of the issues
      2. Identifies root causes and preventative actions within 30 days
    • Complaint Handling
      1. Acknowledges within 24 hours and closes 95% of complaints within 30 days or less
      2. Leads, directs, and ensures customer satisfaction in the resolution of quality failure events
  • Provides leadership analyzing customer returns
  •  CAPA’s
    1. Closes 95% within 60 days
    2. Leads/supports root cause identification of sustainable corrective actions for Corrective and Preventative Actions (CAPAs)
  • Drives continuous improvement by leading formal problem solving events with internal and external teams
  • Explores, researches and maintain appropriate metrology/lab equipment to meet demands of the business
  • Assists and supports customer and prospective client visits as required

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.
  • CQM, CQA preferred

TECHNICAL EXPERIENCE REQUIREMENTS:

  • Experience with APQP, PFMEA, SPC, measurement techniques, metrology, blueprints, and control plans
  • QMS administration, supplier quality development
  • Knowledge of:
    • Thorough understanding of FDA, ISO 13485:2016 requirements and auditing
    • Complaint handling & CAPA process
    • SPC/Trending
    • 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
    • Analyzes and solves problems based on facts
    • Understands, practices and uses fact based problem solving tools (Fishbone, 8D, 5 Why’s, etc.)
  • Analyzes Issues
    • Uses logical rational thought to make good decisions quickly
    • Gathers relevant information systematically
    • Considers a broad range of issues or factors
    • Grasps complexities and perceived relationships among problem or issues
    • Seeks input from others
    • 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
    • Writes effectively; Conveys information clearly and effectively through formal and informal documents
    • 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 all CMP established operating systems (e.g. quality, environmental)
  • Understands the responsibility to maintain; familiarity with our systems and this position’s role in support of these systems, including considering the impact of individual actions on the systems and the responsibility to communicate concerns and improvement ideas

CULTURAL EXPECTATIONS

Our Core Values impact how the business is managed from day to day operational decisions through leadership deployment of long-term strategic planning.

  1. Accountable to our; Employees (well-being), Customers (value), Stakeholders (profitability), Community (stewardship).
  2.  Lead and act with Integrity, Honesty and Respect
  3. Commitment to Operational Excellence Companywide

The entire employee family within Command Medical Products have a common belief in our core values and we are proud of what they stand for. Members joining our team are expected to believe and follow our Core Values by:

  • Being open, fair and honest.
  • By honoring our commitments
  • Having a bias toward action and look at every experience as a learning opportunity
  • Being curious and continuously learning and growing
  • Seeking out new challenges and taking calculated risks
  • Leading by example and providing opportunities for other to learn
  • Being a team player; placing our shared fate above personal ambition
  • Creating an environment free of fear, where healthy conflict leads to better solutions
  • Recognizing  others’ contributions to the team’s success
  • Make a difference by creating something better than what you begin with

This position description is intended to provide a general overview and guide for the activities of this role. The above statements are intended to describe the general nature and level of work and the competencies required by persons assigned to this job.  They are not an exhaustive list of all duties, responsibilities, knowledge, skills, abilities and working conditions associated with this job.