Overview
Quality Control Analyst (Root Cause/Material Inspection) (Pharma/Medical Device) Jobs in Fort Washington, PA at Systems Ally
SUMMARY
The Quality Manager is primarily responsible for ensuring that manufacturing processes meet the highest quality standards. This individual ensures product compliance, quality output, and customer satisfaction by leading the Quality Team and working closely with Production, Engineering, Sourcing, Sales, and outside vendors to identify and resolve quality issues.
The Quality Manager will review processes and procedures identifying opportunities for continual improvement and implementing changes to make the organization more effective and efficient. The Quality Manager is responsible for leading ISO audits and management reviews.
This position is full-time, onsite at our Painesville, Ohio manufacturing facility.
DUTIES AND RESPONSIBILITIES
Act as primary champion of the ISO 9001 compliant Quality Management System (QMS). Coordinate training support where needed.
Ensure Management Reviews are conducted in a timely, productive, and efficient manner.
Conduct regular internal audits between all departments to ensure policies and procedures are compliant to quality standards. Report audit findings and participate in cross-functional resolution of quality issues.
Develop and maintain relationships with key customer’s quality personnel.
Act as primary contact for customers and regulatory bodies regarding quality matters, audits, and inspections. Ensure compliance with all regulatory requirements related to quality control.
Ensure timely, accurate, and compliant validation activities including but not limited to New Product Process Validation and Change Product Process Validation.
Ensure adherence to overall product quality standards; from raw materials to WIP to finished goods (including but not limited to supporting root cause investigations, and verification of completion and effectiveness of timely corrective actions).
Ensure continuous improvement corrective/preventive actions are effectively implemented in a timely manner, as needed to achieve Production and Business Unit Goals.
Develop and maintain quality metrics to track performance and identify areas for improvement
Train and mentor production staff on quality control procedures and best practices
Monitor current systems to identify areas of improvement, updating as needed.
Provide leadership to Quality Department, including performance management including the Quality Assurance personnel.
Manage and maintain calibration program.
Performs other duties as assigned.
Education and Experience
Bachelor’s degree in engineering, manufacturing, or related field required.
Minimum of 5 years’ experience required in quality management preferably in Manufacturing, Electrical / Stamping or Molding.
Minimum of 2 years in a leadership role within a quality department required.
Minimum of 5 years’ experience with ISO9001:2015 QMS required. Knowledge of IPC J Standard a plus.
Previous experience working with Military, Aerospace or Industrial Market Place a plus.
Required Skills/Abilities
Cross-functional leadership abilities. Proven ability to effectively collaborate and influence colleagues in other departments on non-conformances, corrective actions, process improvements, and knowledge/adherence to ANSI/SOSA Technical Requirements.
Demonstrated ability to build respect/trust within internal staff/other functional leaders as well as external Customers and Auditors.
Demonstrated ability to develop and present charts and/or graphs to lead meetings and support business initiatives. Ability to effectively present information and respond to questions from groups of Directors, customers, Team Members and the public.
Ability to analyze data and make timely and appropriate problem-solving decisions based on data findings.
Proficiency in QMS and Microsoft Office Suite.
Excellent time management, prioritization abilities, and effective project management skills.
Ability to travel occasionally for customer visits.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee frequently is required to talk or hear. The employee is occasionally required to stand, walk, and smell. The employee must regularly lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
Benefits
Healthcare benefits
Fully paid life insurance
Health Savings Account with company contribution
401(k) employer match
On-Site Fitness Center
Paid Vacation and Paid Holidays
Tuition Reimbursement
Growth and Development Opportunities
Positive culture of diversity, equity, and inclusion
Meritec (a Qnnect Company) is well-established, growth-oriented, signal integrity leaders and preferred vertically integrated manufacturer of high-performance electrical and electronic interconnect embedded systems and connectors with over fifty-years of innovation, serving world-wide markets with cost-effective solutions.
Qnnect and its affiliated companies are affirmative action/equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Title: Quality Control Analyst (Root Cause/Material Inspection) (Pharma/Medical Device)
Company: Systems Ally
Location: Fort Washington, PA
