CAPA Team Lead

Maintains the Corrective and Preventive Action (CAPA) and Non-Conforming Product Systems. Responsible for overseeing and direction of the 1 Quality System Coordinator.

Primary Responsibilities
Directs activities to resolve all internal/external complaints in the Oliver Healthcare Packaging Grand Rapids facility. This will be done by providing appropriate documentation, risk assessment, routing, corrective and preventive action evaluations, letter preparation, problem solving assistance and FMEA assessments.
Independently interface with the customer through the lifecycle of the complaint through written or verbal communication, including emails, conference calls or investigation letters.
Communicates with the Quality Assurance and Global CAPA Manager regarding critical quality issues of concern.
Monitors and communicates trends in CAPA data to identify areas of opportunity.
Actively engages with other departments to support complaint investigations; lead investigations, observe production activities, interview Subject Matter Experts, etc.
Lead problem-solving activities, root cause analysis, and/or documentation of these activities using industry standard root cause investigation tools.
Lead proactive projects to improve internal processes.
Works with the Quality System Coordinator to ensure they have the necessary support or backup related to the functions of that position.
Participates in customer and ISO registrar QMS audits and provides support for resolving resulting action items.

Provides back up functions for the Quality Manager when requested.

SUPERVISORY RESPONSIBILITIES: (location specific)
Manages one employee in this segment of the Quality Department. Responsible for the overall direction, coordination, and evaluation of this segment. Carries 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 disciplining employees; addressing complaints and resolving problems.

Education

Bachelor’s degree, certification or equivalent in the Medical Packaging industry or Quality Assurance field.

Four years related experience and/or training; or equivalent combination of education and experience in a quality-related position, preferably in a regulated industry such as food, medical device or pharmaceuticals.
Experience
Strong knowledge of GMP and ISO 13485 requirements.
Strong analytical skills, including ability to apply concepts such as fractions, percentages and proportions to practical situations.
Strong knowledge of industry standard root cause investigation tools
Solid verbal and written communication skills.
Strong organizational skills and the ability to effectively manage time and multitask.
Ability to write reports, business correspondence, and procedures.
Software skills including MS Office and SAP.
Read, analyze, and interpret SOPs and Regulatory Standards.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Job Type: Full-time

Pay: $29,869.00 - $89,164.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

Experience:

• Warehouse experience: 1 year (Required)
• Warehouse & Distribution Center Supervisors: 1 year (Required)

Work Location: One location