Established medical device contract manufacturing company in Chicago's West Suburbs looking for a new team member that thrives in an ever-changing work environment.
Our ideal candidate is a passionate self-starter who exemplifies superior management and organizational skills. This role requires dynamic motivation to anchor, as well as accelerate, Quality excellence throughout the organization. Must have excellent oral and written communication skills while working closely with customers, suppliers and internal team members to ensure projects are completed on time and of the highest quality standards. Extensive working knowledge of industry standards, specifically ISO 13485 and 21 CFR 820. MS Outlook and Word, as well as superior MS Excel skills are critical. Our ideal team member displays a positive character of leadership, integrity, self-motivation and dependability.
Summary: Plans, coordinates, and directs quality assurance program designed to ensure quality production of products consistent with ISO 13485, 21 CFR 820 and other established standards, by performing the following duties personally or through subordinates.
Essential Duties and Responsibilities include, but are not limited to, the following.
Manages and performs necessary projects/activities for maintaining and improving the effectiveness of MMI's ISO 13485:2003 certified QMS including, but not limited to the following:
- New Product Design and Development
- Device Design History Files
- Product Specifications, Device Master Records, Bills of Material, Material Specifications, Production and Process Work Instructions
- Validation Programs including Equipment and Process IQ/OQ/PQ
- Sterilization Program for Gamma and EO sterilized product including Validations, Quarterly Dose Audits, Requalifications and Routing Processing
- Complaints, NCR/NCMR, CAPA, SCAR, Deviations
- Internal and External Quality Audits
- Standards Management
- Management Review
- Data Trending and Analysis of Data
- Work Order Review, Release and Certification of Product Conformity
Key project manager for QMS transition from ISO 13485:2003 to ISO 13485:2016.
Develops new approaches to solve problems identified during quality assurance activities.
Formulates and maintains quality assurance objectives complementary to corporate policies and interprets quality philosophy to key personnel in the organization.
Performs quality reviews of design documentation for compliance with stated requirements, including supplier quality manuals, customer specifications and company quality records.
Define problems, collect data, establish facts, and draw valid conclusions for investigations, root cause analysis and actions being taken to improve the situation.
Maintains a working knowledge of government and industry quality assurance codes and standards.
Designs and implements quality assurance training programs to key personnel in conjunction with managers.
Works closely with Operations and key customers and suppliers to monitor and implement goals and actions.
- Must have experience with ISO 13485:2003/2016 and FDA 21 CFR Part 820.
- Bachelor's degree (BA) or equivalent; minimum of five years related experience and/or training; or equivalent combination of education and experience in medical device manufacturing.
- Proven experience in a quality management or relevant role.
- Ability to perform with the highest level of integrity and commitment to quality standards.
- Advanced, working knowledge of Microsoft Office products, specifically master of MS Excel
- Proven ability to lead with propensity for mentoring/positive reinforcement, yet results oriented management style.
- 3 to 7 years experience in a Quality position under ISO 13485 and FDA 21 CFR 820.
- ISO 13485 Lead Auditor certification
- Preferred candidate possesses in-depth knowledge of the quality life-cycle and medical device manufacturing operations.
- In-dept knowledge of Sterilization (Ethylene Oxide, Gamma Radiation) and related processes
Directly supervises our growing Quality Department of 1 to 6 employees. 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. Preferred candidate has proven record of effective leadership abilities, including mentoring/coaching quality associates and support staff.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually moderate.
- Specific vision abilities required by this job include Close vision
- Ability to occasionally lift up to 15 pounds.
Eligible Benefit Programs:
- Group Health Plan, Vision, Dental, Life Insurance
- College Savings Program, Flexible Benefit Plan
- Immediate eligibility: 401(k) Plan, Direct Deposit, Qualified Transportation Benefits, Employee Assistance Program
Compensation based on combination of education and experience.
McFarlane Medical is an established, fast paced medical device contract manufacturing company looking for a new team member that thrives in an ever-changing work environment. With over 30 years experience in design and manufacturing, McFarlane delivers some of the most innovative, world-class minimally invasive surgical devices in the industry, in partnership with industry-leading organizations. We provide our customers with "Turn Key" manufacturing, including first article prototyping, raw material acquisition and management, product forecasting, regulatory management, management of gamma and EO sterilization, and so much more. We pride ourselves in our ability to manufacture high quality medical devices while minimizing costs in the supply chain and manufacturing processes.
"At McFarlane Medical, Inc., our mission is Excellence through Passion. We are committed to providing products and services that are defect-free and meet or exceed both regulatory and customer requirements. We achieve this through our passion for continuous improvement, dedication, pride, and personal responsibility. which prevails as truth throughout our organization from our line operators to our top management team." - M. McFarlane, Sr., President.
Role: Quality Manager
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