Company

Avient CorporationSee more

addressAddressGreenville, SC
type Form of workFull-Time
CategoryHealthcare

Job description

Job Description
DESCRIPTION:
Avient Corporation provides specialized and sustainable material solutions that transform customer challenges into opportunities, bringing new products to life for a better world. Examples include:
• Dyneema®, the world's strongest fiber™, enables unmatched levels of performance and protection for end-use applications, including ballistic personal protection, marine and sustainable infrastructure and outdoor sports
• Unique technologies that improve the recyclability of products and enable recycled content to be incorporated, thus advancing a more circular economy
• Light-weighting solutions that replace heavier traditional materials like metal, glass and wood, which can improve fuel efficiency in all modes of transportation and reduce carbon footprint
• Sustainable infrastructure solutions that increase energy efficiency, renewable energy, natural resource conservation and fiber optic / 5G network accessibility
Avient employs approximately 10,000 associates and is certified ACC Responsible Care®, a founding member of the Alliance to End Plastic Waste and certified Great Place to Work®. For more information, visit www.avient.com .
WHY AVIENT:
Avient Corporation is a world-class sustainable organization built on innovation, collaboration, and employee development. We are committed to providing a supportive and dynamic work environment where our diverse associates can grow and succeed, as well positively impacting our planet and the communities we serve. Our Great Place to Work culture, values, and benefits make Avient an employer of choice for top talent.
We believe diversity of ideas and backgrounds gives us the creativity to be successful in a rapidly changing world. In support of this, we stress equality of opportunity for all qualified individuals in accordance with applicable laws. Decisions on hiring, promotion, development, compensation or advancement are based solely on a person's qualifications, abilities, experience and performance.
Avient Corporation is a drug free workplace. Avient is an equal opportunity employer. We maintain a policy of non-discrimination in providing equal employment to all qualified employees and candidates regardless of race, sex, sexual orientation, gender identity, age, color, religion, national origin, disability, genetic information, protected veteran's status, or other legally protected classification in accordance with applicable federal, state and local law.
PURPOSE OF THE JOB:
To provide Quality Compliance, Direction and Vision for DPM LLC.
• Foster a continuous improvement culture in the MAP quality organization, and operations with regards to product, process and system quality.
• Manage information exchange and coordinate actions between MAP and DBM.
• Manage the MAP operations organization and MAP QA personnel
JOB CONTEXT:
The MAP Manager will operate within the organizational structure to maintaining corporate requirements for the MAP organization. The person in this role will interact with all Avient, APM BV staff, and DBM staff.
• The MAP Manager will also be responsible for tracking/trending of critical quality KPI's on a monthly and quarterly basis to support local and DBM reporting.
• They will participate and approve MOC's for MAP and ensure compliance with APM MOC requirements.
• They will be responsible for coordinating the production and product release schedule with DBM and ensuring compliance to contractual requirements.
• They will be responsible for managing the MAP budget and coordinating budget related activities with finance.
• They will be an expert on the ISO Certification(s) Requirements for ISO 13485, including validation requirements. They will ensure that validation plans, execution strategies and acceptance criteria are based on established site, industry and regulatory standards. They will lead the validation scope of projects. They will oversee complaint investigations, internal notifications, internal audits, supplier audits and CAPA systems. The MAP Manager will approve validation protocols for new product validations.
They will serve as the primary representative for interactions between AMP and DBM related to MAP.
JOB CONTENT:
Key Areas of Accountability / Responsibility
1. All employees have the responsibility to:
a) Show behavior in line with the SHE and Security risks and agreed controls, including being compliant to DSM and DSM Performance Materials requirements, rules and procedures
b) Address any person behaving in a SHE and Security irresponsible way
c) Report any SHE and Security incidents (including observed risks) to management.
2. APM Values - Is expected to be a leading example of Values behavior. Must be able to develop and lead a high performing team in a high support and challenging manner; demonstrating trust, support and respect. Sets the scene for DPM Values and actively encourages and appreciates Values behaviors and thinking and discourages behaviors that do not align with DPM Values. Gives feedback, inside and outside of the team, both positively and for areas of improvement. Creates an environment to enable the team to take the freedom to do what it takes and ensure recognition that with freedom responsibility comes along.
3. Ensure all work is conducted in a safe and effective manner and all applicable procedures and policies are followed by maintaining and enhancing safety awareness programs and related documentation, and taking action to correct unsafe acts, systems and procedures. Ensure that SHE requirements are translated into policies/procedures and adequately communicated within the department.
4. Provide leadership to the MAP organizations by facilitating teamwork within the department and division, providing necessary resources for teams to fulfill objectives, encouraging team members to understand corporate and departmental goals/objectives and needs, providing managerial communication and/or direction to the departments disseminating needed divisional, unit and corporate information to departmental staff on a timely basis and establishing and maintaining an open line of communication with all departmental staff.
5. Responsible for all aspects of the MAP departments including budget and business plan. Monitor and control the department's finances and manufacturing related costs by monitoring monthly expense reports for budgetary compliance as well as investigating and resolving significant variances/problems.
6. Responsible for the MAP organizations structure including staffing levels to meet production volume requirements.
7. Represent APM regarding changes to MAP ISO13485 QMS in conjunction with DBM. Ensure appropriate resources are requested from DBM to operate the MAP organization and resources requested by DBM do not exceed agreed levels.
8. Establish departmental operating goals as part of a MAP Manufacturing Plan.
9. Review and approve site change controls for MAP and regulatory impact and determine requirements for implementation. Determine risk mitigation requirements for changes related to product, process, or system quality.
10. Approve production, validation, NCR, audit reports and/or master batch record documents, procedures, and rationales as required.
11. Comply with relevant laws, regulatory requirements, recipes, SOP's, and other related documents and activities.
12. Comply with all job-related safety and training requirements in a timely manner.
13. Perform other duties as assigned.
Authorities
1. Ensure all work is conducted in a safe and effective manner and all applicable procedures and policies are followed.
2. Establish departmental operating goals in conjunction with DBM.
3. Ensure APM meets DBM contractual requirements.
4. Provide leadership to the MAP organization.
5. Monitor and control the department's finances and manufacturing related costs.
6. Authorized to approve work permits per details included in DYNPRO SHE DYN 026. If so authorized, employee must maintain necessary refresher training to participate in these activities
7. Authorize temporary changes for MAP
Projects or Special Assignments
  1. Other duties as assigned

Qualifications
COMPLEXITY OF THE JOB:
The MAP Manager will interact with DBM and internally withing APM. The position manages Operations and Quality Assurance for MAP. The person must have the a bility to resolve compliance/validation/technical issues based their knowledge of related regulatory requirements. The position requires an understanding and ability to apply statistics. The positions manages quality priorities for MAP and interacts with DBM in that regard.
KNOWLEDGE AND EDUCATIONAL LEVEL:
MS in related technical filed plus 4 years of operations or quality/corporate compliance experience or BS/BA in a technical field plus 6 years of operations or quality/corporate compliance experience or AAS with 7 years of operations or quality/corporate compliance experience or eight years relevant experience.
Demonstrated knowledge of ISO 13485 Standards.
Knowledge of cGMP, validation and medical device compliance is desirable.
Understanding of Statistical principles and tools
Minimum of 2 years managerial or supervisory experience required.
REQUIRED LEVEL OF EXPERIENCES:
  • Experience with ISO Certification process
  • LSS Greenbelt
  • Experience bringing actions long to closure and analyzing trends.
  • Proficient in Microsoft Excel, Microsoft Access, and Microsoft Word.
  • Proficient in Microsoft Outlook and use for tasks, meetings, and other organizational tools.
  • Comprehensive knowledge of ISO13485 including validation requirements.
  • Vert skilled in use of PC and able to learn new software quickly.
  • Able to analyze data and identify trends.
  • Able to process data to others.
  • Able to coordinate team efforts and keep the group informed and organized.
  • Ability to effectively interact with a variety of departments and resolve conflicts.
  • Ability to effectively manage team performance and to identify developmental opportunities for team members.
  • Knowledge of general accounting principles and the ability to develop and deploy capital and expense budgets.
  • Firm understanding of production planning and scheduling activities.
  • Knowledge of environmental regulations related Medical production activities.
  • Ability to drive improvements in production lead times and minimize reject material.

COMPETENCIES:
Each position at Avient focuses on eight Core Competencies as a Leader of Self. Additionally, management positions focus on Leadership Competencies as a Leader of Others and/or a Leader of the Business. These competencies are designed to drive behavior that will ultimately help our associates excel at their current roles, while supporting individual and career development.
ENVIRONMENTAL, HEALTH, SAFETY, & SECURITY (EHS&S) REQUIREMENTS:
Avient integrates EHS&S into all aspects of our operations. Each position at Avient is responsible for complying with all applicable EHS&S requirements. Additionally, employees and management are responsible for reporting all EHS&S incidents immediately to ensure we keep EHS&S a priority within the organization.
Security includes physical security and cyber security.
Refer code: 9089566. Avient Corporation - The previous day - 2024-04-18 22:28

Avient Corporation

Greenville, SC
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