Quality Assurance Manager

Bemis Company Mankato , MN 56002

Posted 3 months ago

If Excellence Drives You, This Is Your Destination.Job Description

ROLE OVERVIEW

The Quality Manager's role is to ensure that products and services produced are of high quality, risk free, and satisfy both internal and external requirements. This includes meeting and exceeding customer expectations in compliance with regulatory requirements. This position has responsibility for managing the people and services provided by the Quality Department. This includes effective interactions with all departments at all levels to ensure continuity of good quality products and services, support for introduction of new products, and qualification of new and revised products and processes. The Quality Department is responsible for insuring that the facility is in compliance with applicable medical/pharmaceutical packaging manufacturing regulations, and that the plant's quality procedures and systems are in compliance with quality system requirements and customer quality protocols.

WHAT YOU GET TO DO

  • Demonstrates safety leadership by complying with all safety rules, policies, regulations and procedures; participating in safety programs, and encouraging employee involvement from all employees in all safety activities.

  • Supports all written safety programs and safety training, acting as a secondary owner of various written safety programs and safety training.

  • Actively manages an Ownership Directive for the BHP site Safety Program.

  • Participates in Incident Investigations for incidents, near misses, and property damage.

  • Participates in all emergency response situations and drills within the plant and also assist other personnel in emergency situations.

  • Participates in periodic safety and housekeeping inspections of all manufacturing departments.

  • Performs all aspects of Human Capital management for any employees reporting directly to the Quality Manager including performance reviews, individual development plans (IDP), human capital planning, building organizational capability, salary planning, and staffing.

  • Understand, support and promote the Bemis Strategy, Bemis/BHP Vision/Mission, and Bemis Core Values.

  • Participates and/or facilitates teams in World Class Operations Management/Lean Six Sigma events.

  • As member of the plant staff, this position will assist in setting direction for all aspects of plant operations including direct vision for plant quality systems.

  • Frequent interactions with customer on all communications related to product/process conformance, root cause corrective actions, customer focused Kaizens, process and product validations.

  • Detailed knowledge and experience on IQ, OQ, PQ process, Failure Mode and Effect Analysis, process capability analysis and improvement and statistical process control

  • Develop, implement, maintain and strive to improve the various components of a quality management system in accordance with the Company's standard operating procedures, external customer requirements and ISO-13485 standards.

  • Manage nonconformities including review of in-process quality failures and determine the disposition of nonconforming materials, correspond with customers and suppliers to resolve problems, and lead root cause investigations through to effective long-term resolutions.

  • Define and implement quality initiatives and programs that result in consistently meeting company quality goals, objectives and KPIs.

  • Develop and implement appropriate in-process quality inspection plans using effective, cost-conscious methods.

  • Responsible for Good Manufacturing Practices (GMP's) installation and maintenance.

  • Functions as ISO Management Representative coordinating ISO contract activities with Registrar.

  • Oversee, delegate, and direct the activities of the Quality team, including supervising the QA Technicians on daily activities. Ensure appropriate shift coverage is maintained at all times. Monitor work load and prioritize as necessary.

  • Identify quality-related training needs, ensuring they are delivered to the appropriate staff on a continuous basis as required.

  • Oversee the internal audit program (quality system, ISO and GMP). This includes coordinating audits, training, issue and close out findings, reporting, tracking, and communicating elevation of issues.

  • Manage frequent external audits (customer and 3rd party audit facilities). This includes coordinating audits, training, issue and close out findings, reporting, tracking, and communicating elevation of issues. Acts as a liaison for BHP customers and external auditors.

  • Coordinate response to customer complaints, including Root Cause, Corrective / Preventive Actions and verification as requested.

  • Periodically plans and conducts on-site audits of supplier's facilities.

  • Actively participate in the internal notification system, including root cause and corrective action support. Provide quality updates to Plant Leadership team as applicable.

  • Execute Corrective / Preventive Action Tasks and Activities.

  • Promotes the awareness of customer requirements and strives to reduce customer complaints.

  • Maintains records and files related to quality assurance activities.

  • Complete customer quality questionnaires and quality surveys.

  • Leads the Quality Pillar in supporting our World Class Operations Management system and provides guidance in creating project teams to enhance the site's quality management system. Participates in other WCOM teams.

  • Perform all other duties and/or projects as required.

  • Assists in maintaining supplier partnerships.

WHAT WE VALUE

  • Technical Knowledge

  • Must have effective communication skills to execute quality programs and communicate with employees at all levels of the plant.

  • Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions.

  • Collaboration and Influencing

  • Strong Customer Service Focus

  • Strong Team Leadership with ability to manage, coach, and develop people, talent and skills.

  • Demonstrate Energy, Empowerment and Execution

  • Lives Bemis Core Values and leads by example

WHAT WE WANT FROM YOU

Bachelor's degree in Engineering or other Technical discipline. Minimum of five (5-7) years of experience related to quality control, quality assurance and/or lab testing in an ISO environment, preferably including three (3) years of experience in a supervisory capacity preferred. Lean Six Sigma Black Belt Certification or a willingness to gain such certification is required.

Broad knowledge of quality assurance concepts and procedures in an ISO environment. Experience with SPC, DOE, GMP, QSR, and FDA requirements. ISO 9000 and/or ISO 13485 audit experience. Must have a thorough understanding of common Quality and Problem Solving tools such as Statistical Analysis, DOE, Pareto charts and Histograms. Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products. Well-developed database and spreadsheet experience. Solid financial reporting acumen. Strong overall computer literacy. Must have effective organizational, problem solving and interpersonal skills to execute quality programs and communicate with employees at all levels of the plant. Exceptional problem solving and analytical skills with the ability to make quick and appropriate decisions. Proficient at multitasking and prioritizing. Well-developed human relations / people management skills; able to delegate authority and provide guidance, direction, goals, feedback and discipline. Easily able to develop positive working relationships.

Bemis Expectations

Bemis is committed to its core values: Ethics, Accountability, Innovation, and Respect. By becoming an employee at Bemis Company, Inc., you will work in a high performing environment where team members collaborate to get the job done, challenge the status quo to find a better way, and embrace unconventional ways of thinking. We are eager to see how you can make an impact in our high performance culture.

Bemis Company, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.


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Quality Assurance Manager

Bemis Company