South Portland, Maine, United States
I am a highly motivated and enthusiastic professional with over 10 years of experience in regulated manufacturing industry in both Quality and Operations leadership positions. Extensive knowledge and experience in project management and Lean methodology including waste identification and elimination, facilitating Kaizen events, root cause analysis, value stream mapping, 5S/6S implementation, etc. My passion is engaging with all functional areas of the business, from the front line employees to leadership, to improve processes, create new standards and empower others to become their own process improvement professionals.
● Manages all quality processes involving the inspection of materials used in manufacturing of medical devices per ISO 13485 and FDA 21 CFR 820; ● Inspects all incoming materials to ANSI/ASQ and ISO sampling plans; ● Participates in material cost savings projects; ● Designed improved work flow procedures to increase release efficiency on all instruments by 60%; ● Assists Supplier Process Engineers in documenting material specifications and incoming inspection processes for new products; ● Participates in Lean events including Kaizens and 5S for various processes; ● Organizes cross-functional participation for solving critical material issues; ● Active member of the Abbott Culture Committee.
● Managed all business transactions, maintaining multiple databases in accounting; attendance, marketing, sales, and inventory; ● Organized scheduling, class format and lesson plans; ● Networked with other local businesses, committees and leaders to strengthen business community.
● Ensured all processes up to finished product met Nestle Waters NA, ISO 9001, and FDA regulations; ● Reviewed SOPs involved with water bottling process and tankard water on a regular basis; ● Charged with enforcing PPE/GMP rules, as well as enforcing a safe workplace per OSHA standards guidelines throughout the plant; ● Directly involved with quality controls associated with changes in design and branding of bottled water; ● Managed various brand labeling of finished product in plant database; ● Tasked with upkeep of the plant’s MSDS system and cataloging of all new incoming chemical agents.
● Ensured all processes up to finished product met Nestle Waters NA, ISO 9001, and FDA regulations; ● Reviewed SOPs involved with water bottling process and tankard water on a regular basis; ● Charged with enforcing PPE/GMP rules, as well as enforcing a safe workplace per OSHA standards guidelines throughout the plant; ● Directly involved with quality controls associated with changes in design and branding of bottled water; ● Managed various brand labeling of finished product in plant database; ● Tasked with upkeep of the plant’s MSDS system and cataloging of all new incoming chemical agents.