Overview
Director, Quality Jobs in New Hope, PA at ORCHESTRA BIOMED, INC.
Job Description:
KEY ACCOUNTABILITIES INCLUDE:
Meetings & Project Management Responsibilities:
Develop, implement, and maintain the ISO 9001 and 27001 ISO Quality Management System.
Plan for and manage ISO 9001 and ISO 27001 certification process for the company along with any renewals, audit cycles, and orchestrating with consultants and third parties
Plan for and form the business teams, committees and members of management required to comprise the Quality Audit Team
Coordinate Management Review Meetings
Participate in the development of a safe and healthy workplace. Comply with instructions given for their own safety and health and that of others, in adhering to safe work procedures. Co-operate with management in its fulfilment of its legislative obligations
Oversee and ensure compliance with the company’s CTPAT membership including managing the recertification process as well as assisting the development of any internal processes to maintain good standing with CTPAT membership
Work with suppliers and vendors to ensure materials and services meet ISO quality standards.
Address customer quality concerns and collaborate with the customer service team to resolve any issues.
Quality Assurance:
Monitor and improve product quality by ensuring adherence to the ISO quality processes.
Lead the implementation of continuous improvement initiatives, ensuring best practices are followed.
Provide training and guidance to staff on ISO-related processes, quality control, and standard operating procedures (SOPs).
Document Control:
Maintain and update all ISO-related documentation, including work instructions, standard operating procedures, quality manuals, and forms.
Prepare and submit regular reports on ISO compliance, audits, and improvement progress to upper management.
Distributing (hard copy) documents to stations
Monitoring implementation of document control procedure and providing assistance to managers as needed in developing/maintaining their documents
Internal & External Quality Audits:
Audit SEKO stations as needed to ensure CTPAT, and security audits are complete and identify any deficiencies found with management to ensure mitigated measures are put into place
Develop audit check list
Conduct internal Quality Audits
Issue audit reports and follow up to ensure deficiencies are corrected
Develop an audit schedule which will include some in person visits to various SEKO stations
Monitor closure of Corrective Actions
Prepare an internal audit report for Management Review
Oversee internal audits, audits by external parties, and ensure corrective and preventive actions (CAPA) are taken.
Quality Software Management & Training
Identify, implement, serve as administrator in the company’s quality control software platform
Train new hires and current employees and work closely with IT in the QMS platform as it relates to any requirements needed for ISO 27001
Is responsible for the overall direction of all company personnel in matters related to the quality system and to all matters related to operational compliance
Risk Management:
Identify areas of potential risk to the quality system and work proactively to mitigate any issues.
Ensure that all machine shop activities follow risk management protocols.
Other duties as assigned by management.
REQUIREMENTS:
Process Management focus and knowledge of global programs and management
Working knowledge of operations & compliance issues
Outstanding written and verbal communication abilities
Familiarity with computers and necessary software
Detail-oriented and well-organized
Strong decision-making and problem-solving skills
Ability to foster strong relationships
Proven understanding of risk assessment and mitigation
Research and reporting skills
Microsoft Software applications i.e., PowerPoint, Excel, Word
CargoWise (Wise Tech) Software applications (preferred knowledge)
Strong knowledge of ISO 9001:27001 standards (or other applicable ISO standards).
Proven track record of managing ISO audits and compliance.
EDUCATION & EXPERIENCE:
Minimum
Bachelors degree in a related field
5-7 years of experience as an ISO Manager or similar role in a related field i.e., Transportation Security Administration (TSA) In-Direct Air Carrier or Logistics and Freight Forwarding experience or Quality or Project Management Experience
Preferred
Masters degree
7-10 years experience
SPECIALIST CERTIFICATIONS:
ISO 9001 Lead Auditor or similar certifications preferred.
Additional certifications in Quality Management (e.g., Six Sigma, Lean) a plus.
SEKO Worldwide is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
About Us
SEKO is a client centric company, so it’s essential that all of our employees have a customer service ethic which drives everything they do, on top of their individual skill sets.
To ensure we retain our position at the forefront of this exciting and rapidly developing industry, we want to find new people to work with us, who understand our five Core Values and want to share in the future success of the business.
SEKO’S CORE VALUES
Respect – for ourselves, all others, and our community
Client Focus – we are in business to serve our internal and external clients, and to satisfy their needs
Integrity – no compromise, hold self accountable for actions
Teamwork – we need to really work together
Fun – work hard, play hard
We have many positions available around the world – including Business Development Executives, Systems Administrators, Operations Coordinators and many others.
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Title: Director, Quality
Company: ORCHESTRA BIOMED, INC.
Location: New Hope, PA
