Sr Quality Engineer

at Promega (view profile)
Location Fitchburg, WI
Date Posted July 3, 2019
Category Biotechnology
Job Type Full-time
Address 5399, 2800 Woods Hollow Rd

Description

Job Description

JOB OBJECTIVE: Sr Quality Engineer, Training will be responsible for transforming and managing key processes within a regulated environment. This role will utilize quality engineering principles and practices to manage and improve quality processes, including the internal training program, and ensure quality system compliance.

ESSENTIAL DUTIES:

1. Collaboratively work with stakeholders and managers to define issues, select projects and prioritize work. Assures projects align with business and quality system objectives by translating strategies into specific work area priorities and action plans.

2. Maintains and improves quality processes, including Training, to ensure compliance with the 21 CFR 820 Quality System Regulation (QSR), ISO9001, and ISO13485.

3. Act as subject matter expert for key quality processes including the internal Training program.

4. Oversees and monitors the training program including processes, procedures, and records for compliance to requirements. Identify gaps, opportunities for process improvements, and facilitates communication for changes that could or may affect Promega operations, customers, or partners.

5. Collaborates with key stakeholders to maintain training policies, procedures, training materials, processes and records which meet Quality System and business needs. Ensure affected employees and management are knowledgeable of training program requirements, systems, and recordkeeping practices, and train those staff as needed.

6. Effectively work with other training staff to manage and deliver internal training. including directing the work of others to meet training program and departmental needs.

7. Lead and implement role-based training programs.

8. Ensures new or modified training materials or practices are communicated to departments and/or individuals affected by these changes and ensure appropriate involvement and communication.

9. Presents a positive and professional image of Promega training to all internal and external customers.

10. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

11. Works with manager to develop budget and resource needs for training program development and delivery.

12. Reports and/or presents project, process, data, or metrics to stakeholders during course of work. Identify issues and recommends solutions to overcome identified issues.

OCCASIONAL DUTIES:

1. Assists in the development of procedures and training programs in other areas of the company develop and deliver special topic training, as needed.

2. Leads or participates cross-departmental or corporate projects or initiatives as assigned.

3. Works with management with executive responsibility on urgent/critical activities or projects needed for the business.

4. Maintain fluency and currency in adult learning theory and practice.

5. Supports FDA, ISO, and other compliance audits.

6. Perform general support and other activities as assigned.

MANDATORY QUALIFICATIONS:

1. Minimum BS degree or equivalent in technical and/or scientific discipline with minimum 11 years of manufacturing/QA experience

2. Over 5 years of experience in designing, developing and redesigning Quality Systems in compliance with quality system regulations and standards including QSR, ISO9001, and ISO13485.

3. Minimum 3 years of experience in project management or supervision, especially in the biotechnology or medical device areas.

4. Able to set priorities for self and possibly others, able to manage various activates without direction from others, readily adjusts to shifts in workload or priorities.

5. High proficiency with electronic quality management systems and able to use various Microsoft products.

6. Demonstrated experience in achieving results in a rapidly changing cross functional environment.

7. Excellent oral and written communication skills, including formal presentations and reports. Able to present information to wide, diverse audience including presentations outside of organization.

PREFERRED QUALIFICATIONS:

1. Independent, self-starter with proven results in problem identification, planning, communication and project management.

2. Ability to work and communicate well with a diverse scientific, business, and organizational group to achieve improvement and operational results.

3. Ability to articulate technical and interpersonal issues and resolve conflict in a constructive manner.

PHYSICAL REQUIREMENTS:

1. Ability to use computer, office tools, and equipment.

 

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