Director of Quality in Plymouth, Minnesota at PROMED MOLDED PRODUCTS INC

The Director of Quality is a member of the senior staff and as such is also expected to participate in senior staff and management review meetings, actively identify and pursue new business opportunities, contribute ideas into the overall management and well-being of the company, serve as a mentor to junior staff and consistently identify and implement new ways to improve the quality of work and job satisfaction for ProMed personnel. Quality has the authority to halt production if product quality is suspect. The Director of Quality ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Position duties and responsibilities include, but are not limited to the following:

• Ensuring that quality and regulatory requirements are established implemented and maintained in accordance with the current ISO 13485 Standard, and FDA 21 CFR 820, 21 CFR 210 & 21 CFR 211 regulations;
• Ensures the Quality Management System activities are developed and deployed in an efficient and effective manner;
• Oversees the approval or rejection of all components, in-process product/materials, packaging materials, labeling and drug product;
• Oversee review and approval or rejection of all controlled documents (procedures, specifications, etc.) that impact product quality;
• Oversee the supplier qualification process;
• Oversee the cGMP/QSR/ISO13485 training programs;
• Oversee the audit program (Customer, FDA, Internal);
• Oversees the Document Control process;
• Oversees Validation activities (Equipment, Process, Clean Room);
• Oversee the review of production records and associated documentation (prior to product release) and assures issues or errors are fully investigated;
• Oversees product release activities and disposition;
• Leads employees through career planning via performance reviews and goal setting;
• Management Representative
• Establishes and tracks ProMed and Pharma quality objectives and reports on the status of the quality management system to the rest of senior management.
• Other duties as assigned

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Master’s degree or advanced degree in business or business leadership.
• Bachelor’s degree in chemistry, biochemistry, engineering, health care, biological sciences, or a related scientific discipline.
• Must have 15 years minimum of quality assurance and regulatory compliance experience in either the development or manufacturing of pharmaceutical and/or combination products.
• Must have hands-on pharmaceutical, Device and Combination Products cGMP experience.
• Technical understanding of Medical Device & Pharmaceutical industry language and contracts.
• Expert knowledge of FDA regulations (21 CFRs 820, 210 & 211), QMS Standard (ISO 13485), Risk Management standard (ISO 14971), ICH, and USP requirements.
• Knowledge of analytical lab activities, validations, and data analysis.
• Strong oral and written communication skills with a demonstrated ability to work in a team environment.
• Strong leadership skills.
• Ability to be flexible, multitask, and deliver on multiple projects simultaneously.
• Proficient computer skills, including MS Word, MS Excel, MS-PowerPoint, and MS-Outlook.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.

• Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
• Exposure to buildings where a variety of chemical substances are used for cleaning, and/or operation of equipment;
• The noise level in the work environment is usually minor;
• Duties are performed indoors;
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

• The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see, and use repetitive motions;
• Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
• The position requires the individual to meet multiple demands from several people and interact with internal and external people;
• Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
• Employee may have duties involving walking on even or uneven surfaces;
• Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
• Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
• It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently.
• Employee must see and hear on a continuous basis as well as speak frequently;
• Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.