Quality Assurance Manager

Job Type

Full-time

Description

Accountable for leading the Quality Assurance at the South Bend, Indiana site. Plans, coordinates, and directs quality assurance activities directly or through delegates to ensure continuous production of products consistent with the Quality Management System. Ensures all products manufactured and services provided by the company meet the applicable quality requirements.

ESSENTIAL FUNCTIONS, included but not limited to:

• Appointed as the local Management Representative.
• Direct activities of the quality system to ensure compliance to both national and international requirements.
• Provide leadership and mentorship in non-conformance management and CAPA processes, by ensuring quality investigations are robust, timely and conducted and documented in accordance with company requirements.
• Oversee of the upkeep of the training program database. Conduct the annual review of the Quality System and cGMP training.
• Coordinate Corrective and Preventative Actions (CAPAs) and non-conformance activities.
• Create and maintain the annual internal audit schedule. Ensure internal auditors are trained. Perform product release functions.
• Write and update standard operating procedures (SOPs).
• Coordinate and serve as point of contact for audits conducted by registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable.
• Support audits conducted by regulatory agencies.
• Ensure Management Review of the QMS is completed and documented to reflect the status of the QMS effectiveness and resulting improvements.
• Develop and maintain performance of site Quality Assurance staff utilizing common practices, quality methodologies, processes, and tools to ensure consistent and effective quality product outcomes.
• Lead, maintain, and improve the QMS in line with ISO 9001 and ISO 13485 to ensure all aspects of the QMS are understood, implemented, and maintained by staff. Assist in development of validation protocols.
• Manage communications with the FDA and other regulatory bodies as needed.
• Implement effect validation strategies in support of continuous improvement with established and evolving regulatory and company requirements.
• Identify and implement continuous improvement strategies on multiple axes, including but not limited to process, tools, methodologies, and functional competencies.
• Interact with all company personnel in coordination of quality activities and sound business practices in compliance with Quality Policy and directives.
• Adhere to current Good Manufacturing Practices(cGMP); Ensure all direct reports comply.
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

OTHER FUNCTIONS:

• Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
• Assist as needed in other areas of the company where training requirements are identified.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Manage Quality Assurance and Quality Control employees.
• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws; Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and discipling employees; addressing complaints and resolving problems.

TRAVEL:

• None required.

Requirements

REQUIRED QUALIFICATIONS:

• Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science or engineering related field.
• Legally authorized to work in the United States.
• Minimum (2) years experience in Quality Assurance Management.
• Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485
• Proven experience leading certification audits (TUV SUD, BSI, FDA etc.) and understanding how to respond to findings, etc.
• Prior manager or supervisory experience.

PREFERRED QUALIFICATIONS:

• Five (5) years experience in Quality Assurance Management.
• Technical knowledge of fermentation and bioprocesses.
• Prior manufacturing experience.

BASIC SKILLS AND ABILITIES:

• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Ability to work independently and as a member of various teams and committees.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Capacity to foster a participative management style advocating a team concept.
• Excellent mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Life Sciences.

Salary Description

$75,000 - $95,000