This position is responsible for operation of post-machining finishing of medical implants in a high-volume manufacturing environment.
1
st
Shift - Mon - Fri, 7:00am - 3:30pm
Essential Responsibilities:
•Develop/maintain strong, internal working relationships
•Understand objectives & mission of ops department & works towards those goals
•Perform hand de-burring, blasting, tumbling & finishing of metal medical implants after machining
•Perform in-process inspection of CNC machined parts
•Package, label & prepare product
•Perform timely & accurate transactions of workflow in ERP system
•Maintain inventories of raw materials & consumables
•Aid in execution of PM activities for all equipment
•Aid in investigation & implementation of corrective actions on product & process failures
•Comply w/all company policies/procedures incl. safety regulations, PPE requirements, SOPs, Work Instructions and GMP
•Interface w/vendors to seek solutions for equipment repairs & refurbishment
•Responsible for upkeep of mfg. areas & providing a clean/safe work environment
•Review all mfg. documents, assembly, inspection, test, packaging procedures
•Support eng. activities such as process validations & equipment qualifications
•Other responsibilities as assigned
Qualifications:
•High school diploma or equivalent. Technical education preferred.
•1-3 yrs of experience in a medical device &/or regulated environment preferred
•Demonstrated English reading, writing and communication skills
•Familiar w/ISO Standards & Good Mfg Practices
•Familiar w/Oracle (or equivalent) ERP systems & Microsoft Office Applications
•Experience w/inspection equipment (calipers, micrometers, comparator)
•Experience w/metal finishing & other post-machining processes
•Experience in lean mfg. environment a plus
•English reading/writing/communication skills
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
Strong organizational, analytical, and time-management skills
Able to self-motivate and work both independently and as part of a team
Manual dexterity and coordination to load and unload parts during finishing operations
Demonstrated organizational skills
Ability to work in a fast-paced environment and multitask. Comfortable with change
Ability to work as part of a team as well as independently
Detail oriented and well organized
Ability to read and interpret engineering drawings and specifications
Familiar with Geometric Dimensioning and Tolerancing
Working Conditions
Ability to lift, pull, and push up to 40lb
Ability to stand for prolonged periods of time
Capable of working in material blending and machining areas with necessary personal protective equipment (eye protection, dust mask, nitrile gloves)
Busy work environment with frequent interruptions
Ability to work overtime, extended hours, and weekends as business demands
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.)
Flexibility to work in multiple manufacturing facilities
restor3d is an Equal Opportunity Employer
$36k-43k yearly est. Auto-Apply 60d+ ago
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Administrator, Imaging Support
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Administrator, Imaging Support will be responsible for daily clerical and administrative functions in support of all aspects of Imaging operations at restor3d. Position is also responsible for planning and developing systems and procedures to improve the quality and efficiency of the department.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d
Understand the objectives, responsibilities, and mission of the Imaging Support department and works towards those goals
Prioritize and plan work activities; adapt for changing conditions
Initiate contact with various hospitals and imaging centers
Create, modify, and maintain documents using Microsoft Office
Maintain electronic filing systems
Support staff in assigned project-based work
Other responsibilities as assigned
Qualifications:
Associates degree in Business Administration or related field is preferred
3+ years' work experience in one of the following areas is required: Customer Service, Medical office/field, Medical device or pharmaceutical experience preferred
Knowledge of medical terminology, with radiology or medical device industry experience preferred
Advanced computer skills including Microsoft Office including Word, Outlook, Excel and Teams
Experience with ERP, PLM, and PACS preferred.
Experience in database entry, CRM or other prospect tracking systems strongly desired e.g. Oracle, SAP)
Excellent telephone etiquette skills
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
Strong organizational, analytical, and time-management skills
Able to self-motivate and work both independently and as part of a team
Strong interpersonal skills
Ability to interact effectively with a large number of individuals both within and outside the organization
Knowledge of customer services practices.
High attention to detail
Exceptional time management and organizational skills, ability to prioritize work, meet deadlines and work under pressure
Ability to manage and develop organized systems for filing, communications, and follow-up
Ability to manage multiple, simultaneous projects and priorities effectively
Ability to sense urgency and respond accordingly
Use of discretion in confidential matters
Flexibility and ability to adapt to changing pace and environment with frequent interruptions
Willingness to learn needed skills on the job in order to enhance performance
restor3d is an Equal Opportunity Employer
$39k-61k yearly est. Auto-Apply 60d+ ago
Manufacturing Technician, 2nd Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of Conformis implants and components.
2
nd
Shift - Mon - Fri, 3:00pm - 11:30pm
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across Conformis.
Understand the objectives, responsibilities, and mission of the Production department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Execute daily maintenance and start-up activities.
Perform machine set-ups.
Perform inspection of components and assembly as required.
Perform cleaning, pouching/sealing, labeling, and sterilization operations.
Strict adherence to Good Documentation Practices when executing all assignments.
Perform timely and accurate transactions of workflow in ERP system.
Participate in inventory cycle counts, variance investigation, and reconciliation.
Assist in performing required process capability studies, equipment installation qualifications, and process validation.
Assist in the investigation and implementation of corrective actions on product and process failures.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Interface with vendors to seek solutions for equipment repairs and refurbishment.
Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
Review all manufacturing documentation, assembly, inspection, test, and packaging procedures, and provide feedback.
Other duties as assigned.
Qualifications:
High School diploma or equivalent; Technical education preferred.
2+ years' work experience in a medical device and/or regulated environment.
Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications.
Familiar with ISO Standards and Good Manufacturing Practices.
Excellent verbal and written communication.
Demonstrated English reading and writing skills.
Ability to understand and follow comprehensive work instructions and guidance documents.
Shipping/receiving/stockroom experience a plus.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Manual dexterity to handle tools, inspection gauges, and equipment of different sizes.
Demonstrated organizational skills.
Ability to work in a fast-paced environment and multitask. Comfortable with change.
Flexible to work overtime, extended hours, and weekends as business demands.
Ability to work as part of a team as well as independently.
Working conditions:
Ability to lift, pull, and push up to 40 lbs.
Ability to stand for prolonged periods of time.
Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time.
Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks).
Busy work environment with frequent interruptions.
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies.
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.).
Conformis is an Equal Opportunity Employer
$34k-50k yearly est. Auto-Apply 60d+ ago
Sales Representative I
Zimmer Biomet 4.4
Boston, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Responsible for attaining sales goals and objectives through the creation and execution of a sales plan in the assigned area. This position will drive sales growth through communication and in-person interactions with current and prospective customers regarding Zimmer Biomet products.
**How You'll Create Impact**
- Builds strong relationships with key surgeons in the given area, while able to cover orthopedic procedures with clinical proficiency and business acumen.
- Builds and implements a sales plan for the assigned area, manages and tracks customer sales activity and prospective customer initiatives, achieves sales targets, reports on sales progress and competitor and customer activities to sales leader, and utilizes the surgery management system to ensure flawless execution of product delivery to the customer.
- Plans, coordinates and executes local educational and sales events, with the support of other internal resources, intended to augment the business and help to deliver assigned sales goals.
- Supports referral network of key surgeons and works with key surgeons to educate referrals on Zimmer products.
- Strictly adheres to all laws and Zimmer policies and SOPs regarding the interaction with HCP's (Health Care Professionals), product handling and complaints, expense reporting, sales activities and training.
_This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._
**What Makes You Stand Out**
- In-depth understanding of customers and their requirements.
- Ability to mentor others based on proven sales track record with customers.
- Ability to become technically proficient with the complete portfolio of products.
- Demonstrated ability to communicate with and influence others.
- Willing and capable of carrying weights up to 50 pounds, independently.
**Your Background**
Bachelor's degree plus a minimum of 2 years' proven experience in orthopedic sales, or a minimum of 6 years' proven sales experience in the medical device industry.
**Travel Expectations**
- Up to 95% predominantly by car, depending on territory.
- Up to 20% overnight travel may be required.
Expected Compensation Range: $75,000 - $85,000 base salary plus commission and bonus.
\#LI-JF2
**Physical Requirements**
EOE/M/F/Vet/Disability
$75k-85k yearly 60d+ ago
Field Inventory Analyst
Zimmer Biomet 4.4
Boston, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Field Inventory Analyst is responsible for day-to-day execution of inventory. Key responsibilities are to maintain the inventory and update the demand based inventory model, reports and underlying data needed to support inventory optimization. The job also entails acting as a liaison with the warehouse to more efficiently manage field inventory and communication processes.
How You'll Create Impact
* Maintain inventory accuracy, reconciliation, cycle count, expiration, and recall.
* Work with sales operations, logistics, and forecasting groups to manage field inventory with accuracy.
* Work to ensure all cases are filled accurately and on time by having accurate inventory.
* Review warehouse data to identify optimization of asset investment.
* Prepare inventory reports: usage, trends, risk assessment, optimal state, etc…
* Review account usage & trends to identify optimal placement of inventory.
* Maintain and develop demand-driven inventory model to assist with Web-based field inventory optimization initiatives.
* Update and support continuous improvement inventory initiatives.
* Justify & order new sets.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
* Possess knowledge of field inventory processes and functions.
* Strong interpersonal skills and ability to achieve results through influence in a team oriented environment.
* Ability to handle multiple priorities and identify creative solutions to complex problems.
* Have understanding of supply chain and business processes including requirements planning, distribution, and sales.
* Advanced Excel skills.
* Effective written and verbal communication skills and how to impact and influence people
Your Background
Bachelor's Degree in Business, Finance, Information Management, or related field.
3-5 years in an operations, inventory, and/or logistics function.
Lean or Six Sigma training preferred.
Travel Expectations
Approximately 50% within the territory
Expected Compensation Range: $70,000 - $80,000
Physical Requirements
EOE/M/F/Vet/Disability
$70k-80k yearly 33d ago
Regional Sales Director
Zimmer Biomet 4.4
Braintree Town, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Provide strategic selling direction for assigned region, including clinical product expertise. Field-based sales management position focused on attainment of Zimmer Biomet sales goals and objectives.
**How You'll Create Impact**
+ Develop relationships with key surgeons to drive sales. Build on these relationships to helpidentify and champion surgeons for Zimmer Biomet faculty, product development, andsurgeon panels. Local surgeon education and management of programs, includingcompliance. Coordinate with local Marketing for planned rollout
+ Direct region sales activities including leading the development of sales plans and to meetbusiness growth objectives, while partnering with regional and national contracts regardingstrategy and pricing approval. Develop business plans to achieve financial results, report onprogress regularly, and develop actions plans to address underperformance.
+ Hire, coach, mentor and develop staff toward maximized performance. Recommend changeswhich support achievement of the regional sales objectives.
+ Demonstrate leadership while applying Zimmer Biomet Values and reinforce adherence toall laws and applicable Zimmer Biomet policies and SOPs regarding the interaction with HCP's (Health Care Professionals), product handling and complaints, expense reporting,sales activities and training.
+ Develop and maintain product line technical expertise and provide support to salespersonnel and customers, including demonstration of Zimmer Biomet product capabilities,key features and advance applications.
**This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.**
**What Makes You Stand Out**
+ Extensive clinical product sales knowledge that leads to identification of market trends and sales strategies.
+ Understanding of Zimmer Biomet products, orthopedic industry and competitor's products and strategies.
+ Strong analytical and problem solving skills.
+ Demonstrated ability to communicate with, lead and influence others.
+ Demonstrated characteristics of high potential for future development opportunities.
**Your Background**
+ Bachelor's degree in Business, Sales, Marketing or technical discipline plus a minimum of 8 years' proven sales/marketing experience in the medical device industry (or related business).
+ Master's degree preferred.
+ Extensive Orthopedic knowledge, including Zimmer Biomet competitor product portfolios.
**Physical Requirements**
**Travel Expectations**
+ Up to 50%
EOE/M/F/Vet/Disability
$103k-162k yearly est. 30d ago
Warehouse Clerk I
Zimmer Biomet 4.4
Braintree Town, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Employee's primary responsibility will be to pick, pack and ship finished goods to customers.
**How You'll Create Impact**
+ Performs work functions to assist department management in accomplishing daily goals, including but not limited to, the picking of Finished Goods, packing of Finished Goods, maintaining inventory accuracy, maintaining a clean, orderly (5S), and safe work environment, and meeting daily shipping requirements, by properly following department OP's and company guidelines.
+ Must be able to understand and perform the functions and procedures pertaining to the efficient operation of warehousing.
+ Must be able to train and direct other personnel in their duties, both clerical and physical.
+ Must maintain good housekeeping in all warehouse areas.
**_This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._**
**What Makes You Stand Out**
+ Understand principles of stock rotation, location and arrangement of materials for efficient handling.
+ Must have an awareness of storage conditions necessary to protect material from damage or deterioration.
**Your Background**
+ High school diploma or equivalent is required.
EOE/M/F/Vet/Disability
$28k-31k yearly est. 8d ago
Preventive Maintenance Technician
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Preventative Maintenance Technician will be responsible for performing maintenance activities on manufacturing equipment. They will also assist manufacturing & facilities with other duties that do not require maintenance.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across Conformis.
Understand the objectives, responsibilities, and mission of the Facilities department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Perform general maintenance on all manufacturing equipment including, but not limited to, the assembly, installation, or repairing of wiring, electrical or electronic components, pipe systems, plumbing, machinery, or equipment.
Assist in the investigation and implementation of corrective actions on product and process failures.
Responsible for upkeep of manufacturing areas to provide a clean and safe work environment.
Support engineering activities such as process validations and equipment qualifications.
Interface with vendors to seek solutions for equipment repairs and refurbishment.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Record completed Preventative Maintenance action to log form as directed by the log form instructions.
Other responsibilities as assigned.
Qualifications:
High school diploma or equivalent. Technical education preferred.
Minimum of 5 years of experience in a medical device and/or regulated environment, preferred.
Electronic/Electrical/Mechanical background preferred.
Experience in a lean manufacturing environment a plus.
Working basic knowledge of hand tools (socket set, metric wrenches, tools, etc.) and must be able to wear the necessary personal protective equipment (safety glasses, ear plugs, non-slip footwear, etc.).
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Familiarity with ISO Standards and Good Manufacturing Practices.
Familiarity with Microsoft Office Applications and common Preventative Maintenance Work Order systems.
Self-starter with strong attention to detail, organizational skills, and the ability to multitask.
Ability to work in a fast-paced environment as part of a team and independently.
Ability to read and interpret engineering drawings and specifications.
Familiar with general machining techniques and practices.
Familiarity with OSHA regulations and standards.
Ability to lift, push, and pull up to 50 lbs.
Ability to stand for prolonged periods of time.
Capable of working in material blending and machining areas with necessary personal protective equipment (eye protection, dust mask, nitrile gloves).
Ability to work overtime, extended hours, and weekends as business demands.
Must adhere to quality and safety standards established by FDA and other regulatory agencies.
Ability to work in changing environments (reduced lighting, increased noise, temperature variances, dust, etc.).
Conformis is an Equal Opportunity Employer
$43k-55k yearly est. Auto-Apply 60d+ ago
CNC Machinist I, 1st Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The CNC Machinist will be responsible for operation of CNC machining centers in a high-volume manufacturing environment. The technician may be asked to support other processes or production lines as demand and production schedules dictate.
1
st
Shift - Mon-Fri, 7:00am - 3:30pm
Essential Duties and Responsibilities:
Develop and maintain strong, internal working relationships across ConforMIS.
Understand the objectives, responsibilities, and mission of the Production department and works towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Operation and light maintenance of CNC machining centers and associated tooling.
Hand deburring of metal medical implants after machining.
Perform in-process inspection of CNC machined parts.
Perform timely and accurate transactions of workflow in ERP system.
Maintain CNC machine spare parts and consumable tooling.
Assist in the investigation and implementation of corrective actions on product and process failures.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions and Good Manufacturing Procedures.
Interface with vendors to seek solutions for equipment repairs and refurbishment.
Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
Review all manufacturing documentation, assembly, inspection, test, packaging procedures and provide feedback.
Support engineering activities such as process validations and equipment qualifications
Other responsibilities as assigned.
Qualifications:
High school diploma or equivalent. Technical education preferred.
1-5 years of experience in a medical device and/or regulated environment.
Demonstrated English reading and writing skills.
Familiarity with ISO Standards and Good Manufacturing Practices.
Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
Strong organizational, analytical and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Experience with inspection equipment (calipers, micrometers, comparator).
Experience with metal polishing and other post-machining processes.
Experience operating and maintaining CNC machining centers.
Experience in a lean manufacturing environment a plus.
Manual dexterity and coordination to load and unload parts during machining operations.
Ability to work in a fast-paced environment and multitask. Comfortable with change.
Ability to work as part of a team as well as independently.
Familiar with Geometric Dimensioning and Tolerancing.
Familiar with general machining techniques and practices.
ConforMIS is an Equal Opportunity Employer
$44k-61k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer II
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Assist in maintaining the quality system in accordance with applicable regulatory requirements.
Identify quality system process improvements and implement solutions.
Lead or assist with the Corrective Action/Preventive Action (CAPA) program.
Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis.
Assist with product inspections as needed.
Perform Internal Quality Audits of the quality system
Participate in supplier selection and approval process, including leading supplier audits and review of quality data.
Perform investigations of non-conformances and drive corrective actions.
Participate on cross-functional product development teams.
Participate in product/process validations.
Perform risk assessments, gathering cross-functional team input.
Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring.
Establish and trend quality metrics and data.
Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements.
Other responsibilities as assigned.
Qualifications:
Bachelor of Science in Engineering, Science, or Biomedical.
2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required.
Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred.
ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Must have a solid knowledge of Microsoft office.
Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
Demonstrated proficiency with FDA and ISO standards for Medical Devices.
Restor3d is an Equal Opportunity Employer
$83k-107k yearly est. Auto-Apply 60d+ ago
SLS Technician I, 2nd Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The SLS Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of restor3d implants and components.
2
nd
Shift - Mon - Fri, 3:00pm - 11:30pm
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Production department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Execute daily maintenance and start-up activities.
Perform machine set-ups and turnovers; load and unload machines as required.
Perform inspection of blended powder and components as required.
Strict adherence to Good Documentation Practices when executing all assignments.
Perform timely and accurate transactions of workflow in ERP system.
Assist in performing required process capability studies, equipment installation qualifications, and process validation.
Assist in the investigation and implementation of corrective actions on product and process failures.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
Other duties as assigned.
Qualifications:
High School diploma or equivalent educational experience required.
Prior experience working in a regulated environment preferred. Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications.
Excellent verbal and written communication.
Demonstrated English reading and writing skills.
Ability to understand and follow comprehensive work instructions and guidance documents.
Skills, Abilities, Competencies Required:
Demonstrated ability to be a team player and work well with others.
Ability to communicate well with other team members.
Ability to work with team members to plan workload, set goals, and achieve team goals on a daily basis.
Able to self-motivate and work both independently and as part of a team.
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Positive attitude and work ethic.
Strong organizational, and time-management skills.
Flexible to work overtime, extended hours, and weekends as business demands.
Ability to receive and follow instructions and communicate with co-workers.
Working conditions:
Ability to physically stand, bend, squat, and lift up to 40 pounds.
Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks).
Busy work environment with frequent interruptions.
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies.
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.).
restor3d is an Equal Opportunity Employer
$36k-50k yearly est. Auto-Apply 60d+ ago
Material Control Coordinator, 1st Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Material Control Coordinator will be responsible for conducting various materials or inventory control functions in support of the company's production and customer requirements, including, but not limited to, shipping, receiving, proper warehousing of materials, and driving company vehicle for the purpose of moving materials between plants as well as vendor locations both in and out of the state of Massachusetts.
1
st
Shift - Mon - Fri, 7:00am - 3:30pm
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Production department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Responsible for proper inventory storage and accuracy through proper controlling of receipts/issuances.
Accurately and timely receive all materials (Inventory, MRO) in a timely basis per the established restor3d guidelines.
Properly bag, tag, label inventory, and practice proper FIFO stock rotation, in a manner to ensure GMP compliance at all times.
Move material between plants as well as to and from vendor locations using the company vehicle.
Track/expedite critical shipments from suppliers.
Coordinate inbound/outbound logistical services (courier, UPS, FedEx) as required.
Coordinate shipments of materials to suppliers (both materials for contract manufacturing and Return To Vendor).
Coordinate domestic and international product shipments.
Interface with all departments to ensure that all inventory/material requests are filled in a timely and accurate manner.
Provide accurate and up-to-date material status reports as required.
Perform Cycle Counts and physical inventories as required to ensure inventory accuracy.
Maintain accurate and timely receiving and outside MFG/CM Logs.
Assist in the set-up/implementation of new tools/systems/methodology to improve/enhance inventory accuracy and service levels.
Assist in the review/resolution of accounts payable/receivable invoice discrepancies, to ensure timely resolution
Evaluate/propose enhancement to current materials handling/storage/flow process to ensure timely availability to the production floor in a GMP compliant manner.
Load and unload company vehicle as needed.
Responsible for the drop-off of restor3d product at our vendors located in various locations and states; Pick-up and return of product back to restor3d facility.
Represent the company in a professional manner when traveling; execute sound judgment while operating the company vehicle to/from delivery locations.
Assist Manufacturing with various tasks as needed and other duties as assigned by management.
Other responsibilities as assigned.
Qualifications:
High School Diploma, GED, or equivalent work experience.
2+ years' experience in a shipping/receiving.
Knowledge of inventory control principles and processes.
Experience with Oracle.
Familiar with ISO Standards and Good Manufacturing Practices.
Proficient in various MS Office applications.
Valid Driver's License with satisfactory driving record.
Pass drug and medical exams per the US DOT requirements.
Able to work flexible and/or extended hours and weekends as business demands.
Experience in a smaller, faced-paced environment desired.
Experience with International Shipping, SED/EEI a plus.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Demonstrated English reading skills.
Demonstrated organizational skills.
Comfortable with change.
Demonstrated flexibility and reliability.
Self-starter attitude with ability to identify improvement opportunities.
Ability to bend at the knees, reach above, pull, and push up to 60 lbs., lift and move materials as needed, and to stand and sit for prolonged periods of time.
Ability to drive company vehicle for extended periods of time but usually no more than 5 hours in each direction.
Good hand-eye coordination and ability to operate a vehicle while trying to find addresses; observing others on the road to ensure you are accident-free while driving.
Excellent vision and evaluation skills, able to watch everything on the road for potential collision, accidents, and mishaps.
Good hearing; able to hear at forced whisper in an ear at five feet without the use of a hearing aid.
Demonstrated map-reading skills.
Good general health in compliance with the DOT regulations.
restor3d is an Equal Opportunity Employer
$35k-44k yearly est. Auto-Apply 60d+ ago
Field Inventory Analyst
Zimmer Biomet 4.4
Boston, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Field Inventory Analyst is responsible for day-to-day execution of inventory. Key responsibilities are to maintain the inventory and update the demand based inventory model, reports and underlying data needed to support inventory optimization. The job also entails acting as a liaison with the warehouse to more efficiently manage field inventory and communication processes.
**How You'll Create Impact**
+ Maintain inventory accuracy, reconciliation, cycle count, expiration, and recall.
+ Work with sales operations, logistics, and forecasting groups to manage field inventory with accuracy.
+ Work to ensure all cases are filled accurately and on time by having accurate inventory.
+ Review warehouse data to identify optimization of asset investment.
+ Prepare inventory reports: usage, trends, risk assessment, optimal state, etc...
+ Review account usage & trends to identify optimal placement of inventory.
+ Maintain and develop demand-driven inventory model to assist with Web-based field inventory optimization initiatives.
+ Update and support continuous improvement inventory initiatives.
+ Justify & order new sets.
_This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._
**What Makes You Stand Out**
+ Possess knowledge of field inventory processes and functions.
+ Strong interpersonal skills and ability to achieve results through influence in a team oriented environment.
+ Ability to handle multiple priorities and identify creative solutions to complex problems.
+ Have understanding of supply chain and business processes including requirements planning, distribution, and sales.
+ Advanced Excel skills.
+ Effective written and verbal communication skills and how to impact and influence people
**Your Background**
Bachelor's Degree in Business, Finance, Information Management, or related field.
3-5 years in an operations, inventory, and/or logistics function.
Lean or Six Sigma training preferred.
**Travel Expectations**
Approximately 50% within the territory
Expected Compensation Range: $70,000 - $80,000
**Physical Requirements**
EOE/M/F/Vet/Disability
$70k-80k yearly 33d ago
Regional Sales Director
Zimmer Biomet 4.4
Concord, MA job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Provide strategic selling direction for assigned region, including clinical product expertise. Field-based sales management position focused on attainment of Zimmer Biomet sales goals and objectives.
**How You'll Create Impact**
+ Develop relationships with key surgeons to drive sales. Build on these relationships to helpidentify and champion surgeons for Zimmer Biomet faculty, product development, andsurgeon panels. Local surgeon education and management of programs, includingcompliance. Coordinate with local Marketing for planned rollout
+ Direct region sales activities including leading the development of sales plans and to meetbusiness growth objectives, while partnering with regional and national contracts regardingstrategy and pricing approval. Develop business plans to achieve financial results, report onprogress regularly, and develop actions plans to address underperformance.
+ Hire, coach, mentor and develop staff toward maximized performance. Recommend changeswhich support achievement of the regional sales objectives.
+ Demonstrate leadership while applying Zimmer Biomet Values and reinforce adherence toall laws and applicable Zimmer Biomet policies and SOPs regarding the interaction with HCP's (Health Care Professionals), product handling and complaints, expense reporting,sales activities and training.
+ Develop and maintain product line technical expertise and provide support to salespersonnel and customers, including demonstration of Zimmer Biomet product capabilities,key features and advance applications.
**This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.**
**What Makes You Stand Out**
+ Extensive clinical product sales knowledge that leads to identification of market trends and sales strategies.
+ Understanding of Zimmer Biomet products, orthopedic industry and competitor's products and strategies.
+ Strong analytical and problem solving skills.
+ Demonstrated ability to communicate with, lead and influence others.
+ Demonstrated characteristics of high potential for future development opportunities.
**Your Background**
+ Bachelor's degree in Business, Sales, Marketing or technical discipline plus a minimum of 8 years' proven sales/marketing experience in the medical device industry (or related business).
+ Master's degree preferred.
+ Extensive Orthopedic knowledge, including Zimmer Biomet competitor product portfolios.
**Physical Requirements**
**Travel Expectations**
+ Up to 50%
EOE/M/F/Vet/Disability
$104k-162k yearly est. 30d ago
Finishing Technician I, 1st Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
This position is responsible for operation of post-machining finishing of medical implants in a high-volume manufacturing environment.
1
st
Shift - Mon - Fri, 7:00am - 3:30pm
Essential Responsibilities:
Develop/maintain strong, internal working relationships
Understand objectives & mission of ops department & works towards those goals
Perform hand de-burring, blasting, tumbling & finishing of metal medical implants after machining
Perform in-process inspection of CNC machined parts
Package, label & prepare product
Perform timely & accurate transactions of workflow in ERP system
Maintain inventories of raw materials & consumables
Aid in execution of PM activities for all equipment
Aid in investigation & implementation of corrective actions on product & process failures
Comply w/all company policies/procedures incl. safety regulations, PPE requirements, SOPs, Work Instructions and GMP
Interface w/vendors to seek solutions for equipment repairs & refurbishment
Responsible for upkeep of mfg. areas & providing a clean/safe work environment
Review all mfg. documents, assembly, inspection, test, packaging procedures
Support eng. activities such as process validations & equipment qualifications
Other responsibilities as assigned
Qualifications:
High school diploma or equivalent. Technical education preferred.
1-3 yrs of experience in a medical device &/or regulated environment preferred
Demonstrated English reading, writing and communication skills
Familiar w/ISO Standards & Good Mfg Practices
Familiar w/Oracle (or equivalent) ERP systems & Microsoft Office Applications
Experience w/inspection equipment (calipers, micrometers, comparator)
Experience w/metal finishing & other post-machining processes
Experience in lean mfg. environment a plus
English reading/writing/communication skills
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
Strong organizational, analytical, and time-management skills
Able to self-motivate and work both independently and as part of a team
Manual dexterity and coordination to load and unload parts during finishing operations
Demonstrated organizational skills
Ability to work in a fast-paced environment and multitask. Comfortable with change
Ability to work as part of a team as well as independently
Detail oriented and well organized
Ability to read and interpret engineering drawings and specifications
Familiar with Geometric Dimensioning and Tolerancing
Working Conditions
Ability to lift, pull, and push up to 40lb
Ability to stand for prolonged periods of time
Capable of working in material blending and machining areas with necessary personal protective equipment (eye protection, dust mask, nitrile gloves)
Busy work environment with frequent interruptions
Ability to work overtime, extended hours, and weekends as business demands
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.)
Flexibility to work in multiple manufacturing facilities
restor3d is an Equal Opportunity Employer
$36k-43k yearly est. Auto-Apply 60d+ ago
Manufacturing Technician, 2nd Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of restor3d implants and components.
2
nd
Shift - Mon - Fri, 3:00pm - 11:30pm
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Production department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Execute daily maintenance and start-up activities.
Perform machine set-ups.
Perform inspection of components and assembly as required.
Perform cleaning, pouching/sealing, labeling, and sterilization operations.
Strict adherence to Good Documentation Practices when executing all assignments.
Perform timely and accurate transactions of workflow in ERP system.
Participate in inventory cycle counts, variance investigation, and reconciliation.
Assist in performing required process capability studies, equipment installation qualifications, and process validation.
Assist in the investigation and implementation of corrective actions on product and process failures.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Interface with vendors to seek solutions for equipment repairs and refurbishment.
Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
Review all manufacturing documentation, assembly, inspection, test, and packaging procedures, and provide feedback.
Other duties as assigned.
Qualifications:
High School diploma or equivalent; Technical education preferred.
2+ years' work experience in a medical device and/or regulated environment.
Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications.
Familiar with ISO Standards and Good Manufacturing Practices.
Excellent verbal and written communication.
Demonstrated English reading and writing skills.
Ability to understand and follow comprehensive work instructions and guidance documents.
Shipping/receiving/stockroom experience a plus.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Manual dexterity to handle tools, inspection gauges, and equipment of different sizes.
Demonstrated organizational skills.
Ability to work in a fast-paced environment and multitask. Comfortable with change.
Flexible to work overtime, extended hours, and weekends as business demands.
Ability to work as part of a team as well as independently.
Working conditions:
Ability to lift, pull, and push up to 40 lbs.
Ability to stand for prolonged periods of time.
Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time.
Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks).
Busy work environment with frequent interruptions.
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies.
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.).
restor3d is an Equal Opportunity Employer
$34k-50k yearly est. Auto-Apply 60d+ ago
Preventive Maintenance Technician, 2nd Shift
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Preventative Maintenance Technician will be responsible for performing maintenance activities on manufacturing equipment. They will also assist manufacturing & facilities with other duties that do not require maintenance.
2
nd
Shift - Mon - Fri, 3:00pm - 11:30pm
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Facilities department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Perform general maintenance on all manufacturing equipment including, but not limited to, the assembly, installation, or repairing of wiring, electrical or electronic components, pipe systems, plumbing, machinery, or equipment.
Assist in the investigation and implementation of corrective actions on product and process failures.
Responsible for upkeep of manufacturing areas to provide a clean and safe work environment.
Support engineering activities such as process validations and equipment qualifications.
Interface with vendors to seek solutions for equipment repairs and refurbishment.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
Record completed Preventative Maintenance action to log form as directed by the log form instructions.
Other responsibilities as assigned.
Qualifications:
High School Diploma, GED, or equivalent work experience; technical education preferred.
Minimum of 5 years of experience in a medical device and/or regulated environment, preferred.
Electronic/Electrical/Mechanical background preferred.
Experience in a lean manufacturing environment a plus.
Working basic knowledge of hand tools (socket set, metric wrenches, tools, etc.) and must be able to wear the necessary personal protective equipment (safety glasses, ear plugs, non-slip footwear, etc.).
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Familiarity with ISO Standards and Good Manufacturing Practices.
Familiarity with Microsoft Office Applications and common Preventative Maintenance Work Order systems.
Self-starter with strong attention to detail, organizational skills, and the ability to multitask.
Ability to work in a fast-paced environment as part of a team and independently.
Ability to read and interpret engineering drawings and specifications.
Familiar with general machining techniques and practices.
Familiarity with OSHA regulations and standards.
Ability to lift, push, and pull up to 50 lbs.
Ability to stand for prolonged periods of time.
Capable of working in material blending and machining areas with necessary personal protective equipment (eye protection, dust mask, nitrile gloves).
Ability to work overtime, extended hours, and weekends as business demands.
Must adhere to quality and safety standards established by FDA and other regulatory agencies.
Ability to work in changing environments (reduced lighting, increased noise, temperature variances, dust, etc.).
restor3d is an Equal Opportunity Employer
$43k-55k yearly est. Auto-Apply 60d+ ago
Product Quality Engineer
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across Conformis.
Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Perform quality testing of CER and Purified water system.
Perform product release activities (on an as needed basis).
Administers the bioburden/endotoxin testing program as required per procedure.
Trend in-process manufacturing data and environmental monitoring data and produce summary reports.
Implement and maintain quality system in accordance to applicable regulatory requirements.
Initiate and participate in resolution of non-conforming materials.
Review Non-Conformity Reports for sub-assemblies and finished goods.
Administer the calibration system.
Review of the daily activities for production start-up.
Develop and upgrade procedures for continuous improvement as required by the quality system.
Perform Internal Quality Audits of the quality system.
Develop qualification/validation plans.
Conduct product/process validations (sterilization).
Develop and implement statistical sampling plans.
Assist in the investigation of product complaints.
Assist in corrective action investigations.
Perform internal audits to drive continuous improvement (minimum of 2 per year).
Other responsibilities as assigned.
Qualifications:
Bachelor of Science in Engineering or Science.
1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications).
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Must have a solid knowledge of Microsoft office 2010.
Knowledge of FDA and ISO standards for Medical Devices is a plus.
Knowledge of Statgraphics or Minitab is a plus.
Conformis is an Equal Opportunity Employer
$83k-107k yearly est. Auto-Apply 60d+ ago
Regional Sales Director
Zimmer Biomet 4.4
Massachusetts job
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
**What You Can Expect**
Provide strategic selling direction for assigned region, including clinical product expertise. Field-based sales management position focused on attainment of Zimmer Biomet sales goals and objectives.
**How You'll Create Impact**
+ Develop relationships with key surgeons to drive sales. Build on these relationships to helpidentify and champion surgeons for Zimmer Biomet faculty, product development, andsurgeon panels. Local surgeon education and management of programs, includingcompliance. Coordinate with local Marketing for planned rollout
+ Direct region sales activities including leading the development of sales plans and to meetbusiness growth objectives, while partnering with regional and national contracts regardingstrategy and pricing approval. Develop business plans to achieve financial results, report onprogress regularly, and develop actions plans to address underperformance.
+ Hire, coach, mentor and develop staff toward maximized performance. Recommend changeswhich support achievement of the regional sales objectives.
+ Demonstrate leadership while applying Zimmer Biomet Values and reinforce adherence toall laws and applicable Zimmer Biomet policies and SOPs regarding the interaction with HCP's (Health Care Professionals), product handling and complaints, expense reporting,sales activities and training.
+ Develop and maintain product line technical expertise and provide support to salespersonnel and customers, including demonstration of Zimmer Biomet product capabilities,key features and advance applications.
**This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.**
**What Makes You Stand Out**
+ Extensive clinical product sales knowledge that leads to identification of market trends and sales strategies.
+ Understanding of Zimmer Biomet products, orthopedic industry and competitor's products and strategies.
+ Strong analytical and problem solving skills.
+ Demonstrated ability to communicate with, lead and influence others.
+ Demonstrated characteristics of high potential for future development opportunities.
**Your Background**
+ Bachelor's degree in Business, Sales, Marketing or technical discipline plus a minimum of 8 years' proven sales/marketing experience in the medical device industry (or related business).
+ Master's degree preferred.
+ Extensive Orthopedic knowledge, including Zimmer Biomet competitor product portfolios.
**Physical Requirements**
**Travel Expectations**
+ Up to 50%
EOE/M/F/Vet/Disability
$104k-160k yearly est. 30d ago
Product Quality Engineer II
Conformis Inc. 4.3
Conformis Inc. job in Wilmington, MA
The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across Conformis.
Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Assist in maintaining the quality system in accordance with applicable regulatory requirements.
Identify quality system process improvements and implement solutions.
Lead or assist with the Corrective Action/Preventive Action (CAPA) program.
Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis.
Assist with product inspections as needed.
Perform Internal Quality Audits of the quality system
Participate in supplier selection and approval process, including leading supplier audits and review of quality data.
Perform investigations of non-conformances and drive corrective actions.
Participate on cross-functional product development teams.
Participate in product/process validations.
Perform risk assessments, gathering cross-functional team input.
Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring.
Establish and trend quality metrics and data.
Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements.
Other responsibilities as assigned.
Qualifications:
Bachelor of Science in Engineering, Science, or Biomedical.
2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required.
Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred.
ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Must have a solid knowledge of Microsoft office.
Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
Demonstrated proficiency with FDA and ISO standards for Medical Devices.
restor3d is an Equal Opportunity Employer
Zippia gives an in-depth look into the details of Conformis, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Conformis. The employee data is based on information from people who have self-reported their past or current employments at Conformis. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Conformis. The data presented on this page does not represent the view of Conformis and its employees or that of Zippia.
Conformis may also be known as or be related to CONFORMIS INC, ConforMIS, ConforMIS Inc, ConforMIS, Inc., Conformis, Conformis Inc and Conformis, Inc.