Quality Manager Jobs

About The Position

Requirements

• Bachelor’s degree in a scientific or engineering discipline required
• Minimum of 6-8 years of related experience
• Experience in a GMP-related field within a Biotechnology, Biologics manufacturing, Medical Device, or similarly regulated manufacturing environment.
• Minimum of 5 years of experience managing and leading quality systems and associated teams at a company or corporate level.
• Experience supporting FDA, Notified Body, or other regulatory inspections or audits.
• Knowledge of global quality system and regulatory requirements, including applicable FDA regulations, ISO 13485, and other relevant standards.
• Strong knowledge of GMP, SOPs, and quality systems in a regulated manufacturing environment.
• Ability to lead multiple assignments in collaboration with department system owners and cross-functional stakeholders.
• Excellent interpersonal, verbal, and written communication skills, with the ability to work independently with scientific and technical personnel.
• English proficiency (oral & written) is required.

Nice To Haves

• Master’s degree preferred.
• Advanced proficiency with Microsoft Office applications and Adobe Acrobat.
• Lead Auditor, Internal Auditor, External Auditor, ASQ, Six Sigma, or related certification preferred.
• Ability to quickly understand technology, medical applications, and applicable regulations and standards.
• Demonstrated ability to create and effectively communicate regulatory and quality system expectations.
• Demonstrated ability to positively influence groups across an organization to align around a common quality philosophy.
• Ability to manage and execute multiple critical projects simultaneously in a fast-paced environment with changing priorities.
• Strong ethics and judgment, including the ability to escalate issues appropriately in the face of competing priorities.
• Travel may be required based on business needs, including potential supplier, site, or audit support.
• Lead Auditor, Internal/External Auditor, ASQ, Six Sigma, or related certification preferred.

Responsibilities

• Supervise Manufacturing and Supplier Quality Engineering associates and support quality metrics, reporting, and resolution of quality issues.
• Lead and support Material Review Board activities, ensuring appropriate resourcing to minimize MRB material value and reduce potential part shortages.
• Conduct external supplier audits, execute CAPA action and effectiveness activities, and support resolution of field complaints.
• Lead, manage, and assign long- and short-term tasks for the Plant Quality Engineering team, including training, development, mentoring, goal setting, and budgeting.
• Develop, improve, and maintain quality objectives, and track and trend performance against those objectives.
• Develop and improve quality data systems and provide regular quality data reporting on a global basis.
• Ensure risk-based quality processes are in place and effectively implemented across relevant areas.
• Support obsolescence programs related to suppliers and ensure appropriate quality input and oversight.
• Ensure effective quality-related communication globally, locally, and across functions inside and outside the department.
• Communicate business-related issues or opportunities to the next management level and ensure compliance with applicable Company, regulatory, Health, Safety, and Environmental requirements.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year