|Supplier Quality Manager
|Job Type: >
||Bachelor of Science
||$ 110000.00 - $ 130000.00
****GREAT OPPORTUNITY FOR A SUPPLIER QUALITY ENGINEERING MANAGER****
This position manages the supplier quality and sustaining engineering functions ensuring compliance with applicable regulations and corporate requirements, supporting quality deliverables for projects related to suppliers of finished goods, intermediates, and raw materials including material changes, supplier changes and related sustaining engineering projects.
- Manage Supplier Quality and Sustaining Engineering team members.
- Responsible for project resourcing, budgeting, project scheduling and cross-functional communication.
- Works with cross-functional stakeholders to develop and maintain a priority list of sustaining engineering and supplier quality engineering projects, including a ranking mechanism to determine project priority level.
- Assigns sustaining engineering team members to projects according to priority (including self, as appropriate; the position is expected to involve a mix of management and hands-on engineering).
- Utilizes industry standard methodologies (DFSS, Six Sigma Lean, agile, kaizen, etc) and tools to solve problems, drive improvement changes and track key metrics to remain on schedule and budget.
- Approves expenditures and makes decisions about the purchase of materials and services.
- Reviews and approves contracts and cost estimates, writes and presents proposals, reports, and findings to senior management.
- Develops, maintains and communicates sustaining and supplier related KPIs and scorecard data.
- Identifies risk within department or business and recommends improvement plan to control risk.
- Works in a team environment with minimal supervision to plan and accomplish specific objectives and to complete tasks per a defined schedule.
- Performs individual assessments and conducts periodic formal and informal performance reviews of direct reports.
- Oversees supplier quality including monitoring, scorecards, audits, quality agreements, SCAR’s, validations, and material changes.
- Ensure quality compliance to FDA, ISO 13485 and applicable regulations and standards.
- Manages the Supplier Quality Audit program including performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documentation.
- Ensure Supplier Quality Agreements are current and accurate.
- Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers.
- Initiate supplier corrective action requests and assist in root cause investigations for supplier related issues.
- Participate in product and process risk management activities.
- Participate in corrective and preventive actions as appropriate.
- May review and approve validation protocols and reports for contract manufacturers and suppliers.
- Other duties as assigned.
- Bachelor's degree from a four-year college or university in a relevant science or engineering discipline.
- Minimum five years experience managing a team of engineers.
- Minimum ten years experience in supplier quality.
- Minimum ten years in medical device manufacturing.
- Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, and repeatability and reproducibility).
- Familiarity with Supplier Scorecards and Supplier Management programs.
- Working knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820.
- Prior experience as an auditor for both suppliers and internal audits.
- Able to travel, both domestic and international up to 15%.
- Master’s degree in Quality Management, Engineering, or related discipline.
- Certified Quality Engineer (CQE).
- Certified Quality Auditor (CQA) or Certified Biomedical Auditor (CBA).
- Experience with continuous improvement, lean practices, and six-sigma.
Required Knowledge, Skills and Abilities:
- Ability to effectively communicate strategies and develop relationships with suppliers.
- Strategic thinker with a desire to be hands on.
- Knowledge of and experience with FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971).
- Knowledge of statistical methods and sampling plan determination.
- Knowledge of Failure Mode and Effect Analysis (FMEA) process.
- Effective verbal and written communication skills.
- Effective organizational skills, which includes time management regarding tasks.
- Excellent data analysis skills and proficiency using Statistical tools (Minitab) in problem solving.
- Analytical problem solving skills.
- Effective computer skills including knowledge of Microsoft Office.
- Ability to effectively manage multiple projects and priorities.
- Ability to successfully work within a team based environment.
- Ability to understand customer needs and requirements.
- Attention to detail.
Diverse Candidates encouraged to apply.